Überblick über die Statistik des Gehaltsniveaus für "Clinical Evaluations Manager in Deutschland"

Location: Italy - home based      Schedule: Full-time, Permanent             CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Clinical Research Associate (CRA II/SCRA).  You will manage clinical projects to ensure quality, budget, and timelines are met while working on projects from our varied client base, ranging from small to mid-sized pharma, biotech, and medical device companies. The studies you will initially be assigned to will be within Oncology, Respiratory, Medical Devices, and Cardiology.                 Join our team and help us deliver clinical trials that will improve patients' lives.               Main Job Tasks and Responsibilities:Keeps professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assignedAssists in the selection of sites, site evaluation visits, initiation visits, and ensuring follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites.May act as Feasibility Associate after appropriate and documented training.Performs training site staff in all study procedures in order to ensure protocol/ICH-GCP compliance.Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness, and quality of the Case Report Form (CRF) in compliance with the protocol, SOP's and ICH-GCP requirements in order to ensure data integrity and subject safety.Conducts source data verification and in-house review of clinical data and ensures timely resolution of data queries to guarantee reliable clinical data.Manages the investigational products (storage, inventory, dispensing records, packaging, and labeling) and the trial material (Investigator study file (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the siteCooperates with the site staff for ensuring proper reporting from the site of the safety issues (such as AEs/SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues.Conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.Will be the main contact person for the site in order to ensure close follow up.Provides general support to the Clinical Research Division on quality control of clinical data.Promptly address the Projects Coordinators/ Project Managers/ Senior Project Managers about any issues that can jeopardize the conduct of the clinical projects assigned.Reports to the Head of Clinical Monitoring Unit on all activities performed during the study and sends all relevant documents according to the timelines and the requirements agreed for each single clinical trial.Develops training material and gives training in collaboration with the Training & Qualification Management UnitMay assist in contract negotiation with sites on study budget after appropriate and documented training.Assists the preparation of the study including CRF design/development, writes CRF instructions, and organizes the study files and documents to ensure good start-up of the investigation sites.May support the submission process in the project (or region), including submission requirements, timelines, informed consent development, etc. after appropriate and documented training.Guides and supervises Clinical Research Associate I (CRA I) in order to coach and train them on the job. Education and Experience:University Degree in scientific medical or paramedical disciplinesPrevious proven experience as a CRA, performing on-site monitoring activitiesStrong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements Specific Role Requirements and Skills:Fluent in EnglishProficiency in Microsoft Office (e.g. Word, Excel, Outlook)Willingness to travel The Benefits of Working in Italy:Meal vouchersMobile phone if requested by the Line ManagerDedicated Line ManagerMonthly meetings with the line managerFull performance and development process with end-of-year reviewsTeam events and end-of-year partyCareer opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationallyEmployee satisfaction survey - your feedback is important for continuous improvement. The Application Process      Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step. If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact mailto:[email protected] for more information.             Who will you be working for?             About CROMSOURCE         CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                            Our Company Ethos      Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.       CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.             Keywords: Clinical Research Associate, CRA, Site Management, Monitor, Monitoring, Oncology, Respiratory, Medical Device, Cardiology, Travel, Submissions, Ethics, Contract Research Organisation, CRO, Permanent, Pharma, Outsourcing.Skills: Cardiology, Oncology, Respiratory, Clinical Research Associate, clinical trials, CRO, Medical Devices, Monitoring, PharmaLocation: ItalyShare: LinkedIn Facebook Twitter Email

Location: United States - Fort Washington, PA, or Cary NC  Schedule: Full-time, Permanent     ClinChoice, the parent company of CROMSOURCE, is a leading full-service clinical CRO dedicated to offering high-quality one-stop services to pharmaceutical, biotechnology, medical device, and consumer products clients, who are dedicated to the professional development of our employees and providing an excellent work-life balance. We are looking for a dynamic person to join our in-house team as an Executive Director of Human Resources in the United States. This role will be office based in either Fort Washington, PA or Cary, NC with flexibility to work from home two days per week. Previous experience with a CRO is required.        The Executive Director of Human Resources will manage day-to-day HR operations in North America and provide strategic leadership and direction to the HR department. This position will be involved in every aspect of Human Resources function in North America including but not limited to organizational HR policy and compliance, talent management, employee relations, performance and benefit reviews, compensation, and other duties as assigned. Additionally, the position will work with the Global Head of HR and other HR Regional Heads to set strategy and ensure standardization and collaboration across the international organization of ClinChoice.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Lead and oversee day-to-day activities for HR functions in North America, including but not limited to HR system evaluation and implementation, HR core functions such as performance review and compensation, benefit, training requirements, terminations, onboarding and offboarding, etc.Lead the development and implementation of HR procedures and policies, and ensure the policies are in compliance with their respective country and local labor laws including health and safety, equal employment opportunity, diversity and inclusion, compensation and benefit requirements, pension plans, taxes, privacy, and any other laws.Team up with the recruitment group to develop cost-effective recruitment strategies and long-term talent acquisition plans to support the company's overall goal and look for creative solutions to meet fast-growing resource needs.Collaborate with other regional HR leads for alignment of the strategies and processes across the international organizations.Collaborate with and support the functional management team to ensure satisfactory employee retention.Prepare and present regularly or as needed to the International HR management team and update North America regional HR and initiatives. Support and contribute to the HR dashboard as needed. Education and Experience:A bachelor's degree in human resources or other fields is required. An MBA or master's degree in human resources or business is preferred.Thorough knowledge of North American (USA and Canada, particularly) employment-related laws and regulations.Experience with human resource information systems.10+ years of experience in Human Resources.  3+ years of leadership roles and team management in Human Resources in North America.Experience in HR management systems, such as ADP, SAP, or other systems.Experience working in a fast-paced, collaborative team environment. Able to work efficiently under pressure and consistently meet tight deadlines.Experience working for a CRO is required. Specific Role Requirements and Skills:Ability to be discreet and handle confidential, sensitive information.Excellent verbal and written communication skills, including presentation skills.Excellent interpersonal and conflict resolution skills.Excellent organizational skills and attention to detail.Strong analytical and problem-solving skills.Strong supervisory and leadership skills.Excellent in Microsoft Word, Excel, PowerPoint, Outlook. The Application Process  Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.        If you would like to discuss the role before applying through the website @ www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.     Who will you be working for?     About CROMSOURCE     CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                      Our Company Ethos  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values are evidenced by our below-industry average turnover rates.     CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.     Keywords: Executive Director of Human Resources, HR Director, HR Manager, Human Resources, Human Resources Director, Human Resources Manager, Compliance, Employee relations management, Recruiting, Retention strategy, HR management, Employment law, Onboarding Management, ADP, SAP, Human Resource Information Systems, HRISSkills: HR Manager, Clinical Research Organisation, CROLocation: United StatesShare: LinkedIn Facebook Twitter Email

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Senior Director, Proteomics Research works on multiple projects that are extremely complex in scope, often across multiple groups and sites. As a technical expert and a leader, the Senior Director, Proteomics Research is responsible for providing overall directions, technical insights, guidance, and mentoring to a large group of scientists to ensure successful planning, design, and execution of proteomics research-related projects. Specifically, the Senior Director, Proteomics Research is responsible for determining the scope, technical difficulty, plan, time, resources, and risks associated with new assignments and projects geared toward protein biomarkers discovery and validation. He/she will be providing leadership and guidance to a team of scientists in Planegg, Germany with the focus on leveraging mass spectrometry to discover biomarkers that help advance cancer diagnosis and treatment. The Senior Director will also be managing the Planegg research facility in which the mass spectrometry research will be performed. This includes day to day operational management, budgeting, and forecasting which are an integral part of the overall research and technology development budgeting and plans. Essential Duties Include, but are not limited to, the following: Provide leadership and technical guidance and mentorship to a team of research associates and scientists. Work on significant and unique issues where analysis, situations, or data requires an evaluation of intangible variables and may impact future concepts, products, or technologies. Work on multiple projects that are extremely complex in scope, often across multiple groups and sites. Determine the scope, technical difficulty, plan, timeline, resources, and risks associated with new assignments and projects. Present and clearly communicate findings of research at data meetings, group meetings, and project team meetings to determine the next steps and the path forward for successful outcomes. Identify, adapt, and advance new technology initiatives. Exercise latitude and independent judgement to determine methods and procedures or technologies on new assignments and provide ideas for new techniques. Maintain thorough knowledge of technological industry developments; provide technical assessment, guidance, and help with Go/No Go decisions when evaluating or developing technologies, methods, and procedures. Provide deep scientific leadership and technical input and help guide decisions affecting project planning and experimental design or product development. Prepare, provide, and present information and data for scientific abstracts, industry conferences, project meetings, or publications. Perform complex analyses and present results and data driven outcomes to Senior Management, as well as to a variety of audiences throughout the organization. Contribute to the intellectual property portfolio by implementing innovative and creative ideas to solve problems or improve on current methods, as well as guide and shape nascent ideas that are presented by the scientists and team members. Provide help with IP disclosure and assist in answering questions related to IP filings. Prepare, review, and approve detailed technical procedures, protocols, and reports. Prepare reports and documentation and provide highly technical analysis or summarization of experimental results and project/study outcomes, next steps and provide future direction of the project, and help senior management/project teams with determining Go/No Go decisions. Share ideas and be receptive to new ideas when collaborating within and across departments. Question the status quo and seek and evaluate improvements to existing technologies, processes, or methods. Undertake independent and collaborative research to meet department and project objectives. Promote an open, collaborative environment built on trust to foster positive teamwork that allows for free exchange of ideas. Invest in developing talent to meet both career goals and the organization's goals. Build strength-based teams; apply diverse skills and perspectives to achieve current and future business needs. Create and deliver high quality presentations that effectively communicate and tie into a cohesive story the project status and/or experimental results. Effectively manage, support, and guide your team, including, but not limited to delegating tasks and responsibilities, assess employee performance and provide helpful feedback and training opportunities. Consistent demonstration of exceptional leadership qualities, including, but not limited to the ability to attract and retain the best team, foster a culture of high performance, lead with integrity, humility, accountability, and courage, and set a clear vision to energize teams towards the future. Ability to effectively work on several varied projects at one time, with frequent changing priorities. Excellent analytical, problem solving, and decision-making skills. Exercise technical proficiency, scientific creativity and rigor, and independent thought when challenging and debating scientific ideas. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company’s Quality Management System policies and procedures. Maintain regular and reliable attendance. Ability to act with an inclusion mindset and model these behaviors for the organization. Ability to work nights and/or weekends, as needed. Ability to lift up to 20 pounds for approximately 5% of a typical working day. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 50% of a typical working day. Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height. Ability to comply with any applicable personal protective equipment requirements. Ability to use various types of laboratory equipment; including microscopes, microtomes, blades, strainers, and pipettes for extended periods of time. May perform repetitious actions using lab tools. Ability to use near vision to view samples at close range. May be exposed to hazardous materials, tissue specimens, and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation. Ability to travel 10% of working time away from work location, may include overnight/weekend/international (to USA) travel. Minimum Qualifications Ph.D. in life sciences, medical technology, clinical laboratory science, chemical/physical/biological science, or field related to the essential duties of the position; or Master’s degree in life sciences, medical technology, clinical laboratory science, chemical/physical/biological science, or field related to the essential duties of the position and 4 years of related experience in lieu of a Ph.D.; or Bachelor’s degree in life sciences, medical technology, clinical laboratory science, chemical/physical/biological science, or field related to the essential duties of the position and 6 years of related experience in lieu of Ph.D. 16+ years of industry or academia experience in biology and/or chemistry. 14+ years of experience in medical device/IVD, biotech, life science, or pharmaceutical industry. 5+ years of experience leading or directing people and/or project teams. Demonstrated experience in mass spectrometry and protein research. Advanced understanding of GMP, ISO, and Quality Systems. Proficient in Microsoft Office to include Excel, Word, and PowerPoint. Demonstrated ability to perform the essential duties of the position with or without accommodation. Preferred Qualifications 20+ years of experience in medical device/IVD, biotech, life science, or pharmaceutical industry. 7+ years of experience leading or directing people and/or project teams. Experience in protein testing platforms, mass spectrometry as a protein discovery tool, and protein research/assay development methods. Experience in developing and running protein ELISA assays. Knowledge of statistical models for data analysis and results reporting. #LI-JR1 Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, email **********. We’ll work with you to meet your accessibility needs. Not ready to apply? Join our talent community and stay up to date on what’s new at Exact Sciences. We are Exact Sciences, and we're changing lives together through earlier detection and smarter answers. https://vimeo.com/660680929Über das Unternehmen:OmicEra Diagnostics GmbH

Location: Belgium - Hybrid  Schedule: Full-time, permanent     Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….       TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Clinical Research MD to join one of our clients, one of the most innovative pharmaceutical companies in the world.     CROMSOURCE is an international CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently while establishing a high-trust environment with their client counterparts.       The Clinical Research MD is a responsible member of a clinical team dedicated to the execution of medical strategies and the clinical and operational implementation of a clinical study. Provides active medical and scientific contributions to a cross-functional clinical team.The Physician provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and contributes to the content of clinical study reports and relevant documents for regulatory filings, and performs medical monitoring. Team matrix interactions include clinical team members, project management, quality assurance, quality monitoring and compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology, and other scientific and business-related disciplines.Main Job Tasks and Responsibilities: Is responsible for medical monitoring/reporting and company safety officer activities.Works on clinical development plans, and trial protocols and contributes to clinical study reports.Evaluates adverse events (pre- and post-marketing) for relationship to treatment.Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting.Interprets, reports, and prepares oral and written product research findings in conjunction with senior clinical staff in preparation for regulatory submissions.Liaises closely with clinical scientists and physicians across programs.Provides medical input to external activities such as liaison with external experts, steering committees, independent data, Monitoring Committees, and other committees related to studies or projects.Medical input related to trial-related questions.Provides medical training to the Clinical Trial Team members and other company stakeholders.Supervises Clinical leader.Assists Regulatory Affairs in the development of drug regulatory strategies.Supports general clinical activities involving product evaluation, labeling, and surveillance.Reviews medical literature and related new technologiesAssess medical publications emerging from the Team and its affiliates. Education and Experience:MD with four years' experience in clinical development in pharma or biotech, or equivalent in Academia, preferably including medical monitoring.Trained in GCP Good knowledge of regulatory requirements/ICH guidelines.Proficient in using Microsoft Office and in data visualization tools.Good organizational skills, able to work as part of a team and independently.Good communication skillsDetailed orientedEnglish oral and written communication skills Our Benefits in Belgium:Competitive SalaryGroup and hospitalization insuranceElectronic meal vouchersInternet reimbursementDedicated Line ManagerRegular face-to-face or phone meetings with the line managerFull annual performance review process The Application Process   Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.    If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected] for more information.     Who will you be working for?      About CROMSOURCE        CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                      Our Company Ethos   Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry-average turnover rates.     About TalentSource Life Sciences    TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.     CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.     Keywords: Clinical Research MD, Physician, CRO, Clinical Research Organisation, Contract Research Organisation, Clinical, Drugs, Medical Devices, Clinical TrialsSkills: Medical Practitioner, Clinical Research Organisation, clinical trials, CRO, Medical DevicesLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Location: United Kingdom - Hybrid (2 days in office)Schedule: Full-time, permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                   Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.  Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: United KingdomShare: LinkedIn Facebook Twitter Email

Location: Belgium - Hybrid (2 days in office)Schedule: Full-time, permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations.     The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information.     Who will you be working for?     About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                    Our Company Ethos  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.     About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.     CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.     Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Location: Italy - Hybrid (2 days in office)Schedule: Full-time, permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.  CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, SubmissionsSkills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: ItalyShare: LinkedIn Facebook Twitter Email

Location: Spain - Hybrid (2 days in office)Schedule: Full-time, permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                   Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.  CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.  Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: SpainShare: LinkedIn Facebook Twitter Email

Location: Netherlands - Hybrid (2 days in office)Schedule: Full-time, Permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations.     The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information.     Who will you be working for?     About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                    Our Company Ethos  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.     About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.     CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.     Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: NetherlandsShare: LinkedIn Facebook Twitter Email

Location: Poland - Hybrid (2 days in office)Schedule: Full-time, permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: PolandShare: LinkedIn Facebook Twitter Email

Location: Belgium - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.Read, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writing.Skills: Medical Writer, CER, clinical trials, CRO, Medical Writing, Outsourcing, PharmacologyLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Location: Netherlands - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.Read, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writingSkills: Medical Writer, CER, clinical trials, CRO, Medical Writing, Outsourcing, PharmacologyLocation: NetherlandsShare: LinkedIn Facebook Twitter Email

Location: Germany - Hybrid (2 days in office)Schedule: Full-time, Permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations.     The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information.     Who will you be working for?     About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                    Our Company Ethos  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.     About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.     CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.     Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: GermanyShare: LinkedIn Facebook Twitter Email

Location: Germany - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.Read, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                   Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writing.Skills: Medical Writer, CER, clinical trials, CRO, Outsourcing, PharmacologyLocation: GermanyShare: LinkedIn Facebook Twitter Email

Location: United Kingdom - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team membersRead, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information.  Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writing.Skills: Medical Writer, CER, CRO, Medical Writing, Outsourcing, PharmacologyLocation: United KingdomShare: LinkedIn Facebook Twitter Email

Location: Poland - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.Read, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writingSkills: Medical Writer, CER, CRO, Medical Writing, Outsourcing, PharmacologyLocation: PolandShare: LinkedIn Facebook Twitter Email

Location: Spain - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team membersRead, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.   About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writing.Skills: Medical Writer, CER, clinical trials, CRO, Medical Writing, Outsourcing, PharmacologyLocation: SpainShare: LinkedIn Facebook Twitter Email

Location: Belgium - Office-basedSchedule: Full Time, Permanent Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….   The sponsor-dedicated division of ClinChoice, is searching for a Regulatory Compliance Specialist to join one of our clients, one of the most innovative pharmaceutical companies in the world. ClinChoice is an international CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with their client counterparts.   The Regulatory Specialist assists and supports the Regulatory Affairs department in the execution of regulatory activities to ensure the timely global commercialization of products in compliance with applicable European regulations and international standards.Main Job Tasks and Responsibilities: Partner with the International execution team in the EMEA region.Coordinate, compile, and submit free distribution certificates.Support product registration internationally; Gather and collate information from the manufacturer as required.Provide support to the international team as requested in the development of relationships with RA affiliates, contribute to the development and implementation of the local registration strategy.Act as the EU regulatory Subject Matter Expert for the portfolio under his or her responsibility, supporting the day-to-day Regulatory Affairs activities.Develop strategic guidance and recommend regulatory requirements relevant to the Franchise.Review internal and external communications of the EMEA that refer to products and/or disease state information (Copy Review Process) and represents the department in relevant forums.Advise and provide regulatory impacts to Supply Chain initiatives for the department, be the Primary Point of Contact for the regulatory distribution controls of medical devices and support associated processes and system development.Write, review, and revise company SOPs, recommend efficiencies to processes, and drive Engineering Change Orders (including but not limited to SOPs, and EU labeling approval).Support announced and unannounced inspections by external and internal functions.Assist with organizational tasks: departmental meetings (logistics, formatting, minutes) and department POs, handling regulatory fees (Ariba).Work closely with internal partners across the organisation (including Legal manufacturers, importers, distributors, regional regulatory affairs, quality, supply chain, marketing, and medical affairs) to ensure that stakeholder voices are incorporated into strategies for product launches and product changes.Provide solutions to a variety of problems of moderate scope and complexity where data analysis requires the evaluation of intangible variables.Responsible for the communication of business-related issues or opportunities to the next level of management.Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.Perform other duties assigned as needed.  Education and Experience: University/bachelor's Degree or Equivalent (Science, Engineering, Technical or Biomedical field or Law preferred).4-6 years of work experience in Regulatory Affairs or Quality Affairs preferredSkills:Good knowledge of medical device regulatory requirements in the EUAbility to work effectively in a matrixed organisation and to build partnerships with regional and franchise colleagues.Demonstrate project management skills.Proactive identification of new insights and solutionsExcellent communication, influencing, and presentation skills.Strong output orientation and sense of urgencyExcellent written and verbal communication skills in English (required) The Benefits of Working in Belgium:Competitive SalaryGroup and hospitalisation insuranceElectronic meal vouchersInternet reimbursementCompany Car with fuel card depending on the function.Dedicated Line Manager The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected] for more information. Who will you be working for?   About ClinChoice      CROMSOURCE is now a ClinChoice Company. ClinChoice is a leading full-service CRO dedicated to offering high-quality one-stop service to the pharmaceutical, biotechnology, medical device and consumer products clients. Some of these services include Clinical Operations, Project Management, Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, and Pharmacovigilance. ClinCHoice has established major delivery centres across US, Canada, China, Europe, India, Japan and the Philippines. It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence across Asia, North America, and Europe.      Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. Keywords: Regulatory Compliance Specialist, RA, Compliance Specialist, Regulatory Specialist, Medical Devices, Regulatory, Regulatory Affairs, Pharmaceutical, Pharma, CRO, Contract Research Organisation, Outsourced, Sponsor-dedicatedSkills: Regulatory Affairs Associate, CRO, Medical Devices, Outsourcing, Pharma, Pharmaceutical, Regulatory, Regulatory OperationsLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Bonus - New, full-time MA employees are eligible for a taxable bonus of $750.00 to be paid out after the successful completion of your first 90 days of employment.About UsNorth Shore Physicians Group (NSPG), the largest multi-specialty physicians group north of Boston, is a leader in innovative practices. We are explorers at heart! Here, ideas come from everyone—to the benefit of everyone we serve.We continually seek the best ways to streamline care for both patients and providers. Our medical team of more than 400 physicians, nurse practitioners, physician assistants, and other care professionals is consistently working together to discover new ways to improve and enhance our practices to benefit the health of our patients and the careers of our providers.With NSPG as your employer, you'll experience clinical excellence, supportive practice environments, and opportunities for career advancement! Through our team-based approach, the goal is to make our practice of medicine smarter and more efficient.LocationWe are located at 331 Highland Avenue in Salem, MA. As an Internal Medicine office, we provide physical examinations, routine health screenings and preventative care for adults. The office is open Monday through Friday 8am-5pm.Are you ready to bring your exceptional skills to this innovative practice and join us in driving medicine forwardWhat You Will DoUnder direction of a registered nurse, physician, or mid-level provider, the Medical Assistant is responsible for assisting physicians, nurse practitioners, physician assistants and nurses with: Evaluation Management Treatment of patients during and between office visits Other tasks consistent with the Medical Assistant's training and skills The Medical Assistant's Primary Roles Are Assure efficient patient flow through the office Function as a 'flow manager' Maintain neat, clean, and safe patient care areas Promote patient satisfaction by interacting with patients in a professional, friendly manner consistent with their needs. Required Completion of a formal, post-secondary clinical training program (ex. Medical Assistant, EMT, Paramedic, Nursing Assistant) OR Matriculation in, or graduate of, an Associates or Bachelor's degree program in nursing (RN). Nursing students must have completed fundamentals of nursing, skills lab, and at least one clinical rotation in medical / surgical nursing.Preferred Certificate, Diploma or Associates Degree in Medical Assisting from an accredited program. 2 years of experience in a related physician's office setting.Primary LocationMA-Salem-SLM 331 HighlandWork LocationsSLM 331 HighlandJobMedical AssistantOrganizationNorth Shore Physicians Group(NSPG)ScheduleFull-timeStandard Hours40ShiftDay JobEmployee StatusRegularRecruiting DepartmentNorth Shore Physicians GroupJob PostingJan 19, 2024 Standort Mass General Brigham - Salem Hospital, Salem

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary: Responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure. Serves as the main point of contact at a country level for internal and external stakeholders. Position Responsibilities: Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s Assessment and set up the of vendors during study start up period (locally) Investigator Meeting participation and preparation Ensures data entered in Clinical Trial Managements Systems is current and complete and access to eDC and vendor systems is available for the Country and clinical trial site personnel Validation of study related materials (i.e. protocol, ICF, patient material) Responsible for preparing country specific documents (e.g. global country specific amendment) Prepares materials for Site Initiation Visits Responsible for verifying and confirming with local team eTMF completeness (Country and Site level) Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues. Coordination of database locks and query follow up. Ensures timelines are met. Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion. Lead study team meetings locally Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable) Management of Site relationships (includes CRO related issues) May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs) May perform site closure activities, including post-close out May act as point of contact for Sites May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances. Depending on the experience and previous knowledge of the specific candidate, the position may be adjusted to the Senior Level. Senior Level Expectations: Engage with Protocol Manager, line management and/or Head of Clinical Operations to assist in the resolution of complex issues both locally and/or globally Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned) Position Requirements: Degree Requirements: Bachelors or Masters degree required. Field of study within life sciences or equivalent Experience Requirements: Clinical Trial Manager: Minimum of 4 years' industry related experience Senior Clinical Trial Manager: At least 6 years of industry related experience Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives Key Competency Requirements: Thorough understanding of GCP, ICH Guidelines and Country regulatory environment In depth knowledge and understanding of clinical research processes, regulations and methodology Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management Demonstrated organizational and planning skills and independent decision-making ability Strong organization and time management skills and ability to effectively manage multiple competing priorities Ability of critical thinking and risk analysis. Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels Skilled in the use of technology Good verbal and written communication skills (both in English and local language). Software that must be used independently and without assistance (e.g., Microsoft Suite): Microsoft Suite Clinical Trial Management Systems (CTMS) Electronic Data Capture Systems (eDC) Electronic Trial Master File (eTMF) Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs. This fixed-term role is meant as maternity cover until 30.06.2025. #LI-Hybrid If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **********. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.Über das Unternehmen:0044 BMS GmbH&Co.KGaA Germany