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

Location: Belgium - Home and Office based    Schedule: Full Time         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 Project Manager to join a one of our partner companies. Our client is a global biopharmaceutical company which brings therapies to people that extend and significantly improve their lives through the discovery, development and manufacture of healthcare products.         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 whilst establishing a high-trust environment with the client counter-parts.           Main Job Tasks and Responsibilities:  Initiates and manages all operational study/project activities and serves as primary point of contact for the assigned Core Project teamsTranslates protocol/project strategies from a concept into an executable study/projectFocuses upon the operational integrity and feasibility of individual studies utilizing a variety of resource solutions to ensure the most effective, efficient, and high quality study/project is designed and executedParticipates in and influences the operational strategy for study/project delivery including milestone deliverables to optimize use of time, cost and resourcesParticipates in the identification, assessment and mitigation of risks at the study levelMaintains continuous communication between partner lines, strategic partners, Clinical Research Units (CRU), contractors and vendorsOptimize Operational Control and EffectivenessAssures close partnership with study investigators to assure successful study delivery and high quality dataFosters positive community attitudes and volunteer trust through professional behavior and ongoing communication Education, Experience and Skills:Minimum of BA/BS in a biomedical discipline or equivalent education/training is requiredAt least 5 years relevant experience in clinical research and drug development with clinical operations experiencePreferably with first experience in early drug development (Phase I and IIa)Substantial clinical operations and pharmaceutical industry experience in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issueExperience in Project Management and leadership of matrix teams is essentialFluent in speaking and reading English. Preferably, your second language would be French or DutchDrug development experience including familiarity with: Clinical study management and monitoring, Project/process management, Data management, Clinical & regulatory processes, Regulatory submissions, Budget / expense management, Experience of Vendor Management, Scientific excellence, Administrative excellence, Systems technologyInitiating and Implementing Change: Innovation, Learning Organization, Flexibility and Resilience, Courage with Decisiveness to Act, Problem Solving, Positive approach, forward thinking, challenge the status quoMatrix leadership skills: Influencing, Collaborative, supportive, Networking and Alliance Building, Personal Leadership, Team work, Communication, Negotiation, Decisive and assertive, Change agile, Able to deal with ambiguityEase in using Office tools suite (Excel, Powerpoint, Word, Outlook, etc…)Good organizational skills for seamless interactions with Core Study Teams, Investigators, Regulatory Department and Clinical staff The Benefits of Working in BelgiumCompetitive SalaryGroup and hospitalisation insuranceElectronic meal vouchersInternet reimbursementCompany Car with fuel card depending on the functionDedicated Line ManagerRegular face-to-face or phone meetings with line managerFull annual performance review processAd-hoc team 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 acknowledgement that we received it. If you have the requirements we need, you will be invited for 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 [email protected] for more information.         Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family owned international, full-service Contract Research Organisation who, 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.         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 the 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 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 Project Manager, Clinical Trial Manager, Clinical Study Manager, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicatedSkills: Clinical Project ManagerLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Location: Poland- Home based        Schedule: Freelance, Various FTEs                                    CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Project Manager II, to join their clinical operations team in Poland. This is a full-time opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                      As a Clinical Project Manager II, you will be responsible for managing the clinical projects and ensuring the quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines, and other applicable regulations.                                Join our team and help us deliver clinical trials that will improve patients' lives.        Main Tasks and Responsibilities:Manage and coordinate the assigned clinical projectsManage all project-specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team membersKeep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assignedKnowledgeable in the application process for clinical studies, in force in the country/ies of work.Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)May act as a Technical Specialist supervising the projects within specific therapeutic and technical areasAssure the proper timelines of the assigned projectsManage the budget for the projectMonitor the workload and the performance of the project teamPlan and monitor the tasks of the team in the specific areasCoordinate the Clinical Research Associates and Clinical Monitors activityCollaborate with Clinical Trial Administrators and Clinical Research Associates in terms of local authorities' approval activitiesCollaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Collaborate with the CTAs in archiving activitiesAssist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study ReportsDeliver project-specific trainingOrganise and participate in Monitor and Investigator MeetingsOrganise or take part in the periodic project update meetingsProvide project updates to the Sponsor, Senior Project Manager, and Project Director/Leader as requiredInform the Project Director/Leader about any issuesPerform co-monitoring visits for the assigned clinical projects as necessaryAct as a tutor for Project Coordinators and Project Managers IMaintain relationships with the Sponsor, including providing project updatesPrepare the SOPs relating to clinical research activities in collaboration with the Quality System UnitCollaborate in complying with enforcing Company procedures Education and Experience Required:University Degree in scientific, medical, or paramedical disciplinesProven experience in clinical project management activities, 5 plus years in the CRO/pharmaceutical industry including previous experience as a CRA or similarExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel 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 [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. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage 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: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research Organisation  Skills: Clinical Project Manager, Clinical Study Manager, clinical trials, ICH-GCP, Project Management, EnglishLocation: PolandShare: LinkedIn Facebook Twitter Email

Location: Germany- Home based        Schedule: Freelance, Various FTEs                                  CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Project Manager II, to join their clinical operations team in Germany. This is a full-time opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                      As a Clinical Project Manager II, you will be responsible for managing the clinical projects and ensuring the quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines, and other applicable regulations.                                Join our team and help us deliver clinical trials that will improve patients' lives.        Main Tasks and Responsibilities:Manage and coordinate the assigned clinical projectsManage all project-specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team membersKeep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assignedKnowledgeable in the application process for clinical studies, in force in the country/ies of work.Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)May act as a Technical Specialist supervising the projects within specific therapeutic and technical areasAssure the proper timelines of the assigned projectsManage the budget for the projectMonitor the workload and the performance of the project teamPlan and monitor the tasks of the team in the specific areasCoordinate the Clinical Research Associates and Clinical Monitors activityCollaborate with Clinical Trial Administrators and Clinical Research Associates in terms of local authorities' approval activitiesCollaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Collaborate with the CTAs in archiving activitiesAssist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study ReportsDeliver project-specific trainingOrganise and participate in Monitor and Investigator MeetingsOrganise or take part in the periodic project update meetingsProvide project updates to the Sponsor, Senior Project Manager, and Project Director/Leader as requiredInform the Project Director/Leader about any issuesPerform co-monitoring visits for the assigned clinical projects as necessaryAct as a tutor for Project Coordinators and Project Managers IMaintain relationships with the Sponsor, including providing project updatesPrepare the SOPs relating to clinical research activities in collaboration with the Quality System UnitCollaborate in complying with enforcing Company procedures Education and Experience Required:University Degree in scientific, medical, or paramedical disciplinesProven experience in clinical project management activities, 5 plus years in the CRO/pharmaceutical industry including previous experience as a CRA or similarExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel 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 [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. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage 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: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research Organisation  Skills: Clinical Project Manager, Clinical Study Manager, clinical trials, ICH-GCP, Project Management, EnglishLocation: GermanyShare: LinkedIn Facebook Twitter Email

Location: Spain - Home based          Schedule: Freelance, Various FTEs                                      CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Project Manager II, to join their clinical operations team in Spain. This is a full-time opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                          As a Clinical Project Manager II, you will be responsible for managing the clinical projects and ensuring the quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines, and other applicable regulations.                                    Join our team and help us deliver clinical trials that will improve patients' lives.            Main Tasks and Responsibilities:Manage and coordinate the assigned clinical projectsManage all project-specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team membersKeep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assignedKnowledgeable in the application process for clinical studies, in force in the country/ies of work.Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)May act as a Technical Specialist supervising the projects within specific therapeutic and technical areasAssure the proper timelines of the assigned projectsManage the budget for the projectMonitor the workload and the performance of the project teamPlan and monitor the tasks of the team in the specific areasCoordinate the Clinical Research Associates and Clinical Monitors activityCollaborate with Clinical Trial Administrators and Clinical Research Associates in terms of local authorities' approval activitiesCollaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Collaborate with the CTAs in archiving activitiesAssist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study ReportsDeliver project-specific trainingOrganise and participate in Monitor and Investigator MeetingsOrganise or take part in the periodic project update meetingsProvide project updates to the Sponsor, Senior Project Manager, and Project Director/Leader as requiredInform the Project Director/Leader about any issuesPerform co-monitoring visits for the assigned clinical projects as necessaryAct as a tutor for Project Coordinators and Project Managers IMaintain relationships with the Sponsor, including providing project updatesPrepare the SOPs relating to clinical research activities in collaboration with the Quality System UnitCollaborate in complying with enforcing Company procedures Education and Experience Required:University Degree in scientific, medical, or paramedical disciplinesProven experience in clinical project management activities, 5 plus years in the CRO/pharmaceutical industry including previous experience as a CRA or similarExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel 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 [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. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage 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: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research Organisation  Skills: Clinical Project Manager, Clinical Study Manager, clinical trials, ICH-GCP, Project Management, EnglishLocation: SpainShare: LinkedIn Facebook Twitter Email

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: Poland - home-basedSchedule: Freelance - 0.5 FTE 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 Associate to join one of our sponsors in Poland. This sponsor is focused on developing innovative immuno-oncology and precision medicines. 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 whilst establishing a high-trust environment with the client counterparts.   Main Job Tasks and Responsibilities: Verify safety and well-being of study subjects are maintained for assigned study sites.Support the operational execution of clinical trials and ensure the collection of high-quality, substantiated data.Execute clinical trial activities following established standard operating procedures, good clinical practices, and regulatory requirements.Accountable for study site performance and providing high-quality data according to overall project timeline.Assist Clinical Operations staff and study site staff in quickly and effectively resolving issues.Respond to problems and assist in implementing corrective and preventive actions, if required.Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.Responsible for supporting patient recruitment and retention activities.Performs site visits and ensures the study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies, and procedures.Assists with internal communication of important clinical data and events.Support the organization of Investigators and other study training meetings, if required.Functions as a reliable, trusted resource for accurate, up-to-date study site status knowledge, as requested by key stakeholders.Understand the business value of clinical projects and balance overall business objectives and functional needs.May be involved in other tasks to support Clinical Operations and Operating Company as needed.Support the implementation of new clinical systems/processes.Interface and collaborate with Investigators contractors/vendors, and company personnel as needed.May be asked to provide additional support to Clinical Operations staff, as needed. Education and Experience:A Bachelor's Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing, or Biological Science.At least 3 years of relevant experience.Previous immune-oncology experience, early phase trial experience monitoring, or equivalent experience required.Relevant industry certifications preferred.Experience and knowledge working with computer systems (Microsoft Office - Excel, Word, and PowerPoint).English Written and verbal communications.Presentation and influencing.Strong organizational skills (e.g., able to manage multiple subprojects and tasks simultaneously and consistently meet all associated deadlines).Ability to travel up to 80% of the time.Full driving license. The Application ProcessOnce 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 [email protected] for more information. Who will you be working for? About CROMSOURCE     CROMSOURCE is a family-owned international, full-service Contract Research Organisation who, 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.                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: Contract Research Assistance, CRA, Freelance, FL, Contract, Temporary, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicatedSkills: Clinical Research Associate, Freelance, Clinical Research Organisation, clinical trials, CRO, OutsourcingLocation: PolandShare: LinkedIn Facebook Twitter Email

Location: Spain - home-basedSchedule: Freelance - 1.00 FTE 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 Associate to join one of our sponsors in Spain. This sponsor is focused on developing innovative immuno-oncology and precision medicines. 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 whilst establishing a high-trust environment with the client counterparts.   Main Job Tasks and Responsibilities: Verify safety and well-being of study subjects are maintained for assigned study sites.Support the operational execution of clinical trials and ensure the collection of high-quality, substantiated data.Execute clinical trial activities following established standard operating procedures, good clinical practices, and regulatory requirements.Accountable for study site performance and providing high-quality data according to overall project timeline.Assist Clinical Operations staff and study site staff in quickly and effectively resolving issues.Respond to problems and assist in implementing corrective and preventive actions, if required.Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.Responsible for supporting patient recruitment and retention activities.Performs site visits and ensures the study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies, and procedures.Assists with internal communication of important clinical data and events.Support the organization of Investigators and other study training meetings, if required.Functions as a reliable, trusted resource for accurate, up-to-date study site status knowledge, as requested by key stakeholders.Understand the business value of clinical projects and balance overall business objectives and functional needs.May be involved in other tasks to support Clinical Operations and Operating Company as needed.Support the implementation of new clinical systems/processes.Interface and collaborate with Investigators contractors/vendors, and company personnel as needed.May be asked to provide additional support to Clinical Operations staff, as needed. Education and Experience:A bachelor's degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing, or Biological Science.At least 3 years of relevant experience.Previous immune-oncology experience, early phase trial experience monitoring, or equivalent experience required.Relevant industry certifications preferred.Experience and knowledge working with computer systems (Microsoft Office - Excel, Word, and PowerPoint).English Written and verbal communication.Presentation and influencing.Strong organizational skills (e.g., able to manage multiple subprojects and tasks simultaneously and consistently meet all associated deadlines).Ability to travel up to 80% of the time.Full driving license. The Application ProcessOnce 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 [email protected] for more information. Who will you be working for? About CROMSOURCE     CROMSOURCE is a family-owned international, full-service Contract Research Organisation who, 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.                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: Contract Research Assistance, CRA, Freelance, FL, Contract, Temporary, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicatedSkills: Clinical Research Associate, Freelance, Clinical Research Organisation, clinical trials, CRO, OutsourcingLocation: SpainShare: LinkedIn Facebook Twitter Email

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.Als führendes globales Auftragsforschungsinstitut (CRO) mit einer Leidenschaft für wissenschaftliche Präzision und einer jahrzehntelangen Erfahrung in der klinischen Entwicklung, bietet Fortrea Kunden aus der Pharma-, Biotechnologie- und Medizintechnikbranche ein breites Spektrum an Lösungen für die klinische Entwicklung, den Patientenzugang und die Technologie in mehr als 20 Therapiebereichen. Mit über 19.000 Mitarbeitern, in mehr als 90 Ländern, verändert Fortrea die Arzneimittel- und Medizinprodukteentwicklung für Partner und Patienten auf der ganzen Welt. Als Clinical Project Manager in unserer Abteilung Flexible Solutions sind Sie von zentraler Bedeutung für die erfolgreiche Durchführung komplexer klinischer Studien (Phasen II und III) in Deutschland. Sie arbeiten dabei direkt mit einem der globalen Top 5-Pharmaunternehmen zusammen. Diese Position ermöglicht es Ihnen, an der Entwicklung innovativer Medikamente, die einen neuen Standard insbesondere im Bereich der Onkologie setzen, mitzuwirken, während Sie exklusiv für einen unserer wichtigsten internationalen Kunden tätig sind.Wenn Sie Verantwortung übernehmen, Ihre Führungsqualitäten ausbauen und Ihr umfassendes Know-how in der klinischen Forschung einsetzen möchten, dann ist diese Position eine großartige Gelegenheit. Kommen Sie zu uns und überzeugen Sie sich selbst, warum mehr als 90 % der 20 weltweit führenden Pharmaunternehmen seit vielen Jahren zu unseren Kunden zählen!Was Sie von uns erwarten dürfen:eine bedeutungsvolle Tätigkeit in einem stabilen, diversen, erfolgreichen und angesehenen Unternehmeneine attraktive und konkurrenzfähige Vergütung, einschließlich 13. Gehalt und Urlaubsgeldeine echte Work-Life-Balanceflexible Arbeitszeiten sowie betriebliche Regelungen zum FreizeitausgleichReisezeit = Arbeitszeitein umfassendes Onboarding mit Unterstützung durch Ihren persönlichen Mentoreinen unbefristeten Home-Office-Arbeitsvertrageinen attraktiven, arbeitgeberfinanzierten Pensionsplanhervorragende Fortbildungs- und Entwicklungsmöglichkeiten sowie Unterstützung bei Ihren persönlichen Weiterbildungsplänenkontinuierliche Unterstützung durch Ihren Line Manager, Ihr Team sowie über 20'000 Kolleg*innen weltweitIhre Aufgaben:Verantwortlich für die erfolgreiche Durchführung Ihrer Studien in Deutschland von Feasibility bis StudienabschlussBindeglied zwischen Global Headquarter, Country Operations und den StudienteamsAufbau und Pflege vertrauensvoller, nachhaltiger Beziehungen zu den Prüfärzten, den Studienzentren sowie dem lokalen StudienteamIhr Background:Naturwissenschaftlicher Hochschulabschluss in einem relevanten Fachbereich wie z.B. Biologie, Biochemie, Chemie, Gesundheitswesen, Pharmakologie, Medizin usw.; alternativ eine abgeschlossene Berufsausbildung im Bereich Gesundheit/Pflege oder gleichwertige Berufserfahrung (z. B. als Study Nurse, Research Nurse, Studienkoordinator*in..)Fundierte Berufserfahrung im Projektmanagement klinischer industrie-gesponsorter Studien (Onkologie-Erfahrung wünschenswert)Gute Kenntnis der deutschen Einreichungsprozesse bei Ethikkommissionen und BehördenFührungsqualitäten durch Coaching, Mentoring und/oder Koordination von Teamseffizientes Zeitmanagement und Organisationstalent sowie eine sorgfältige, detailgenaue Arbeitsweiseausgezeichnete Kommunikationsfähigkeiten in verhandlungssicherem Deutsch sowie gute Englischkenntnisse in Wort und Schrift sind ein MussFortrea sucht aktiv nach motivierten, lösungsorientierten und kreativen Denkern, die unsere Leidenschaft für die Überwindung von Hindernissen bei klinischen Studien teilen. Unser Ziel ist es, den Entwicklungsprozess zu revolutionieren und sicherzustellen, dass lebensverändernde Ideen und Therapien schnellstmöglich Patienten zur Verfügung gestellt werden. Werden Sie Teil unseres außergewöhnlichen Teams und profitieren Sie von einem kollaborativen Arbeitsumfeld, in dem Ihre persönliche Entwicklung gefördert wird und Sie einen bedeutenden globalen Einfluss ausüben können. Weitere Informationen über Fortrea finden Sie unter www.fortrea.com.REMOTE#LI-AR1Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.Fortrea is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see our Privacy Statement.

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

THE ROLE Vantis verbessert die Gesundheitsversorgung chronisch kranker Menschen mit digitalen Behandlungen und moderner Arztbehandlung vor Ort. Um dies nicht nur zu behaupten, sondern auch zu zeigen, führen wir klinische Untersuchungen und Analysen durch. Der/die Clinical Research Associate/Managerin (m/f/d) nimmt auf diesem Weg eine Schlüsselrolle ein: Erstens untersuchst Du in klinischen Studien bzw. Anwendungsbeobachtungen den Erfolg unserer Behandlung, zweitens entwickelst Du unseren Behandlungsansatz aktiv weiter. Deine Arbeit verbessert also sowohl die digitalen Vantis Produkte, als auch die vor Ort Behandlung und damit die Gesundheit von vielen Patienten. Typische Aufgaben: Entwerfe, zusammen mit dem klinischen Team, geeignete klinische Studien Betreue die Studiendurchführung in enger Zusammenarbeit mit unseren Prüfzentren: von der Initiierung und Training des Zentrumspersonals bis hin zum Monitoring. Behalte die Rekrutierung, Zentrumsperformance und Qualität ständig im Blick und löse Herausforderungen proaktiv Werte die Daten aus und bringe Deine Erkenntnisse überzeugend auf den Punkt – damit trägst Du Dein Wissen in die Produktentwicklung, das Marketing, zur Zulassung, … Unterstütze unser klinisches Team bei Forschungsanträgen, der Erstellung klinischer Berichte und Literaturrecherchen WHAT YOU NEED TO SUCCEED Du hast ein abgeschlossenes naturwissenschaftliches / medizintechnisches Studium oder die Ausbildung eines medizinischen Heilberufs abgeschlossen (z.B. Krankenschwester, MTA) Mindestens 2 Jahre Berufserfahrung bzw. sowie Vorerfahrung im Umgang mit klinischen Studien nach GCP, z.B. als Researcher, Monitor oder als Study Nurse Eigenverantwortliche, strukturierte und lösungsorientierte Arbeitsweise gepaart mit einer hands-on Mentalität Starke Kommunikationsfähigkeit und souveränes Stakeholdermanagement Sehr gute Deutsch und Englischkenntnisse in Wort und Schrift WHY VANTIS Purpose: Deine Arbeit wird direkt dazu beitragen, die Lebensqualität von Herz-Kreislauf-Patienten zu verbessern Impact: Sei Teil eines gut finanzierten Startups und gestalte die Produkte und die Organisation mit Personal Development: Erlebe eine innovative, aufgeschlossene und temporeiche Arbeitsatmosphäre mit hochmotivierten Kollegen Flexibility: Nach der Eingewöhnung passt die Rolle sehr gut hybrid (min. 25% im Büro). Über uns Bei Vantis stehen wir an vorderster Front der medizinischen Innovation. Mit einem starken Fokus auf Technologie und chronischen Krankheiten arbeiten wir daran, die traditionelle Gesundheitsversorgung radikal zu verbessern. Wie machen wir das? Durch die Kombination digitaler Behandlungswege und einer maßgeschneiderten, patientenzentrierten Versorgung vor Ort. Wenn du Lust hast, die Zukunft der Medizin mitzugestalten und Teil eines dynamischen und zukunftsorientierten Teams zu werden, bist du bei uns genau richtig! Standort Vantis, Munich

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

Job Summary :Medpace is the leading CRO for Biotech companies and is continuing to add Clinical Trial Managers of different experience levels to join our Clinical Trial Management Group in the DACH region, specifically in Munich, Germany. Clinical Trial Managers with expertise in CNS and Neuroscience are welcome to continue to work in their area of expertise or to expand to a new therapeutic area. We provide remote flexibility after probation to the DACH region only with relevant experience. We offer a very competitive salary/bonus program, plus equity grants which have become very lucrative for our associates.Responsibilities :Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulationsServe as primary Sponsor contact for operational project-specific issues and study deliverablesMaintain in depth knowledge of protocol, therapeutic area, and indicationProvide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is providedReview and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicableDevelop operational project plansManage risk assessment and executionResponsible for management of study vendorManage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverablesQualifications :Bachelor’s degree in a health or life science-related field; Advanced degree in a health or life science-related field preferred;Experience in Phases 1-4; Phases 2-3 preferred;Minimum of 2 years of Clinical Trial Management experience, CRO experience preferred;5+ years of Project Manager/Clinical Trial Manager experience at a CRO required for a remote-based role;Management of overall project timeline;Bid defense experience preferred; andStrong leadership skills.Medpace Overview :Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.Why Medpace? :People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace PerksHybrid work-from-home options (dependent upon position and level)Competitive PTO packagesCompany-sponsored employee appreciation events Employee health and wellness initiativesFlexible work scheduleCompetitive compensation and benefits packageStructured career paths with opportunities for professional growthAwardsRecognized by Forbes as one of America's Best Mid-size Companies in 2021, 2022 and 2023Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect NextA Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets Über das Unternehmen:Medpace, Inc.

Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care. Job Description Primary Function of Position: The Clinical Sales Associate will help maximize the utilization of installed da Vinci Surgical Systems. Roles and Responsibilities: Implement the clinical sales plan defined by the Clinical Sales Manager to drive utilization of the da Vinci Surgical System. Become a da Vinci Surgery expert mainly across core indications for the region in order to support the development of surgical robotics programs in the assigned territory. Support regional Sales and Marketing development events that create system awareness and procedure adoption. Develop a da Vinci Surgery plan for each surgical team to insure they are capable of using the system independently within a reasonable time frame based on their volume and access to the system. Drive utilization of the da Vinci system by working with surgical teams to review and select appropriate cases and ensure consistent usage of the da Vinci. Drive continuous expansion of the user base by working with key hospital staff and surgeon thought leaders to develop a qualified lead funnel; interactions with C-level, senior hospital staff and KOL's would be supported by the Clinical Sales Manager. Lead surgical teams through training sessions, helping them understand system operations, OR integration and da Vinci Surgery applications. Be a resource to the surgical team, providing guidance and insight on the use of the da Vinci Surgical System through providing case support. Responsibly manage administrative tasks; reporting of sales/procedures, outcomes of sales activities, submission of expense reports, etc. Qualifications Required Knowledge, Skills, and Experience: Bachelor’s degree or equivalent experience required. Minimum of two years of experience in support and training in medical device industry or minimum of two years of prior sales experience in healthcare. Successful experience as sales support or successful experience in Sales. Excellent interpersonal skills and communication skills. Fluent in English and German language. Ability to travel up to 50%, dependent upon account distribution. Proven ability to work effectively as part of a team. Knowledge of the Operating Room environment preferred. Additional Information Intuitive ist ein Arbeitgeber, der gleiche und gerechte Beschäftigungsmöglichkeiten bietet. Wir bieten allen qualifizierten Bewerbern und Mitarbeitern gleiche Beschäftigungsmöglichkeiten, unabhängig von ethnischer Herkunft, Geschlecht, Schwangerschaft, sexueller Orientierung, Geschlechtsidentität, nationaler Herkunft, Hautfarbe, Alter, Religion, geschütztem Veteranenstatus, Behindertenstatus, genetischen Informationen oder einem anderen Status, der nach den geltenden Gesetzen auf Bundes-, Landes- oder lokaler Ebene geschützt ist, und verbieten jegliche Form von Diskriminierung und Belästigung. Gemäß den „Fair Chance“-Gesetzen berücksichtigen wir qualifizierte Bewerber, die verhaftet wurden oder Vorstrafen haben, für offene Stellen. Standort Intuitive, Germersheim

Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care. Job Description Primary Function of Position: The Clinical Sales Associate will help maximize the utilization of installed da Vinci Surgical Systems. Roles and Responsibilities: Implement the clinical sales plan defined by the Clinical Sales Manager to drive utilization of the da Vinci Surgical System. Become a da Vinci Surgery expert mainly across core indications for the region in order to support the development of surgical robotics programs in the assigned territory. Support regional Sales and Marketing development events that create system awareness and procedure adoption. Develop a da Vinci Surgery plan for each surgical team to insure they are capable of using the system independently within a reasonable time frame based on their volume and access to the system. Drive utilization of the da Vinci system by working with surgical teams to review and select appropriate cases and ensure consistent usage of the da Vinci. Drive continuous expansion of the user base by working with key hospital staff and surgeon thought leaders to develop a qualified lead funnel; interactions with C-level, senior hospital staff and KOL's would be supported by the Clinical Sales Manager. Lead surgical teams through training sessions, helping them understand system operations, OR integration and da Vinci Surgery applications. Be a resource to the surgical team, providing guidance and insight on the use of the da Vinci Surgical System through providing case support. Responsibly manage administrative tasks; reporting of sales/procedures, outcomes of sales activities, submission of expense reports, etc. Qualifications Required Knowledge, Skills, and Experience: Bachelor’s degree or equivalent experience required. Minimum of two years of experience in support and training in medical device industry or minimum of two years of prior sales experience in healthcare. Successful experience as sales support or successful experience in Sales. Excellent interpersonal skills and communication skills. Fluent in English and local language as required. Ability to travel up to 50%, dependent upon account distribution. Proven ability to work effectively as part of a team. Knowledge of the Operating Room environment preferred. Additional Information Intuitive ist ein Arbeitgeber, der gleiche und gerechte Beschäftigungsmöglichkeiten bietet. Wir bieten allen qualifizierten Bewerbern und Mitarbeitern gleiche Beschäftigungsmöglichkeiten, unabhängig von ethnischer Herkunft, Geschlecht, Schwangerschaft, sexueller Orientierung, Geschlechtsidentität, nationaler Herkunft, Hautfarbe, Alter, Religion, geschütztem Veteranenstatus, Behindertenstatus, genetischen Informationen oder einem anderen Status, der nach den geltenden Gesetzen auf Bundes-, Landes- oder lokaler Ebene geschützt ist, und verbieten jegliche Form von Diskriminierung und Belästigung. Gemäß den „Fair Chance“-Gesetzen berücksichtigen wir qualifizierte Bewerber, die verhaftet wurden oder Vorstrafen haben, für offene Stellen. Standort Intuitive, Weiden

Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care. Job Description Primary Function of Position: The Clinical Sales Associate will help maximize the utilization of installed da Vinci Surgical Systems. Roles and Responsibilities: Implement the clinical sales plan defined by the Clinical Sales Manager to drive utilization of the da Vinci Surgical System. Become a da Vinci Surgery expert mainly across core indications for the region in order to support the development of surgical robotics programs in the assigned territory. Support regional Sales and Marketing development events that create system awareness and procedure adoption. Develop a da Vinci Surgery plan for each surgical team to insure they are capable of using the system independently within a reasonable time frame based on their volume and access to the system. Drive utilization of the da Vinci system by working with surgical teams to review and select appropriate cases and ensure consistent usage of the da Vinci. Drive continuous expansion of the user base by working with key hospital staff and surgeon thought leaders to develop a qualified lead funnel; interactions with C-level, senior hospital staff and KOL's would be supported by the Clinical Sales Manager. Lead surgical teams through training sessions, helping them understand system operations, OR integration and da Vinci Surgery applications. Be a resource to the surgical team, providing guidance and insight on the use of the da Vinci Surgical System through providing case support. Responsibly manage administrative tasks; reporting of sales/procedures, outcomes of sales activities, submission of expense reports, etc. Qualifications Required Knowledge, Skills, and Experience: Bachelor’s degree or equivalent experience required. Minimum of two years of experience in support and training in medical device industry or minimum of two years of prior sales experience in healthcare. Successful experience as sales support or successful experience in Sales. Excellent interpersonal skills and communication skills. Fluent in English and German language. Ability to travel up to 50%, dependent upon account distribution. Proven ability to work effectively as part of a team. Knowledge of the Operating Room environment preferred. Additional Information Intuitive ist ein Arbeitgeber, der gleiche und gerechte Beschäftigungsmöglichkeiten bietet. Wir bieten allen qualifizierten Bewerbern und Mitarbeitern gleiche Beschäftigungsmöglichkeiten, unabhängig von ethnischer Herkunft, Geschlecht, Schwangerschaft, sexueller Orientierung, Geschlechtsidentität, nationaler Herkunft, Hautfarbe, Alter, Religion, geschütztem Veteranenstatus, Behindertenstatus, genetischen Informationen oder einem anderen Status, der nach den geltenden Gesetzen auf Bundes-, Landes- oder lokaler Ebene geschützt ist, und verbieten jegliche Form von Diskriminierung und Belästigung. Gemäß den „Fair Chance“-Gesetzen berücksichtigen wir qualifizierte Bewerber, die verhaftet wurden oder Vorstrafen haben, für offene Stellen. Standort Intuitive, Speyer

Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care. Job Description Primary Function of Position: The Clinical Sales Associate will help maximize the utilization of installed da Vinci Surgical Systems. Roles and Responsibilities: Implement the clinical sales plan defined by the Clinical Sales Manager to drive utilization of the da Vinci Surgical System. Become a da Vinci Surgery expert mainly across core indications for the region in order to support the development of surgical robotics programs in the assigned territory. Support regional Sales and Marketing development events that create system awareness and procedure adoption. Develop a da Vinci Surgery plan for each surgical team to insure they are capable of using the system independently within a reasonable time frame based on their volume and access to the system. Drive utilization of the da Vinci system by working with surgical teams to review and select appropriate cases and ensure consistent usage of the da Vinci. Drive continuous expansion of the user base by working with key hospital staff and surgeon thought leaders to develop a qualified lead funnel; interactions with C-level, senior hospital staff and KOL's would be supported by the Clinical Sales Manager. Lead surgical teams through training sessions, helping them understand system operations, OR integration and da Vinci Surgery applications. Be a resource to the surgical team, providing guidance and insight on the use of the da Vinci Surgical System through providing case support. Responsibly manage administrative tasks; reporting of sales/procedures, outcomes of sales activities, submission of expense reports, etc. Qualifications Required Knowledge, Skills, and Experience: Bachelor’s degree or equivalent experience required. Minimum of two years of experience in support and training in medical device industry or minimum of two years of prior sales experience in healthcare. Successful experience as sales support or successful experience in Sales. Excellent interpersonal skills and communication skills. Fluent in English and German language. Ability to travel up to 50%, dependent upon account distribution. Proven ability to work effectively as part of a team. Knowledge of the Operating Room environment preferred. Additional Information Intuitive ist ein Arbeitgeber, der gleiche und gerechte Beschäftigungsmöglichkeiten bietet. Wir bieten allen qualifizierten Bewerbern und Mitarbeitern gleiche Beschäftigungsmöglichkeiten, unabhängig von ethnischer Herkunft, Geschlecht, Schwangerschaft, sexueller Orientierung, Geschlechtsidentität, nationaler Herkunft, Hautfarbe, Alter, Religion, geschütztem Veteranenstatus, Behindertenstatus, genetischen Informationen oder einem anderen Status, der nach den geltenden Gesetzen auf Bundes-, Landes- oder lokaler Ebene geschützt ist, und verbieten jegliche Form von Diskriminierung und Belästigung. Gemäß den „Fair Chance“-Gesetzen berücksichtigen wir qualifizierte Bewerber, die verhaftet wurden oder Vorstrafen haben, für offene Stellen. Standort Intuitive, Kaiserslautern

Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care. Job Description Primary Function of Position: The Clinical Sales Associate will help maximize the utilization of installed da Vinci Surgical Systems. Roles and Responsibilities: Implement the clinical sales plan defined by the Clinical Sales Manager to drive utilization of the da Vinci Surgical System. Become a da Vinci Surgery expert mainly across core indications for the region in order to support the development of surgical robotics programs in the assigned territory. Support regional Sales and Marketing development events that create system awareness and procedure adoption. Develop a da Vinci Surgery plan for each surgical team to insure they are capable of using the system independently within a reasonable time frame based on their volume and access to the system. Drive utilization of the da Vinci system by working with surgical teams to review and select appropriate cases and ensure consistent usage of the da Vinci. Drive continuous expansion of the user base by working with key hospital staff and surgeon thought leaders to develop a qualified lead funnel; interactions with C-level, senior hospital staff and KOL's would be supported by the Clinical Sales Manager. Lead surgical teams through training sessions, helping them understand system operations, OR integration and da Vinci Surgery applications. Be a resource to the surgical team, providing guidance and insight on the use of the da Vinci Surgical System through providing case support. Responsibly manage administrative tasks; reporting of sales/procedures, outcomes of sales activities, submission of expense reports, etc. Qualifications Required Knowledge, Skills, and Experience: Bachelor’s degree or equivalent experience required. Minimum of two years of experience in support and training in medical device industry or minimum of two years of prior sales experience in healthcare. Successful experience as sales support or successful experience in Sales. Excellent interpersonal skills and communication skills. Fluent in English and German language. Ability to travel up to 50%, dependent upon account distribution. Proven ability to work effectively as part of a team. Knowledge of the Operating Room environment preferred. Additional Information Intuitive ist ein Arbeitgeber, der gleiche und gerechte Beschäftigungsmöglichkeiten bietet. Wir bieten allen qualifizierten Bewerbern und Mitarbeitern gleiche Beschäftigungsmöglichkeiten, unabhängig von ethnischer Herkunft, Geschlecht, Schwangerschaft, sexueller Orientierung, Geschlechtsidentität, nationaler Herkunft, Hautfarbe, Alter, Religion, geschütztem Veteranenstatus, Behindertenstatus, genetischen Informationen oder einem anderen Status, der nach den geltenden Gesetzen auf Bundes-, Landes- oder lokaler Ebene geschützt ist, und verbieten jegliche Form von Diskriminierung und Belästigung. Gemäß den „Fair Chance“-Gesetzen berücksichtigen wir qualifizierte Bewerber, die verhaftet wurden oder Vorstrafen haben, für offene Stellen. Standort Intuitive, Pforzheim

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe. Als führendes globales Auftragsforschungsinstitut (CRO) mit einer Leidenschaft für wissenschaftliche Präzision und einer jahrzehntelangen Erfahrung in der klinischen Entwicklung, bietet Fortrea Kunden aus der Pharma-, Biotechnologie- und Medizintechnikbranche ein breites Spektrum an Lösungen für die klinische Entwicklung, den Patientenzugang und die Technologie in mehr als 20 Therapiebereichen. Mit über 19.000 Mitarbeitern, in mehr als 90 Ländern, verändert Fortrea die Arzneimittel- und Medizinprodukteentwicklung für Partner und Patienten auf der ganzen Welt. Als Clinical Trial Assistant in unserer Abteilung Flexible Solutions sind Sie von zentraler Bedeutung für die erfolgreiche Durchführung komplexer klinischer Studien (Phasen II und III) in Deutschland. Diese Position ermöglicht es Ihnen, an der Entwicklung innovativer Medikamente, die einen neuen Standard in der Behandlung unzähliger PatientInnen weltweit - insbesondere im Bereich Onkologie - setzen, mitzuwirken, während Sie exklusiv für einen unserer wichtigsten internationalen Kunden an deren Standort in München tätig sind. Wenn Sie auf der Suche nach einer Aufgabe sind, in der Sie Ihr Organisationstalent und Ihr gutes Auge für Details ebenso einsetzen können wie Ihre Kommunikationsfähigkeiten gegenüber so unterschiedlicher Zielgruppen wie Prüfärzten, Studienteams und Behörden, dann ist dies eine hervorragende Gelegenheit. Kommen Sie zu uns und überzeugen Sie sich selbst, warum mehr als 90 % der 20 weltweit führenden Pharmaunternehmen seit vielen Jahren zu unseren Kunden zählen! Was Sie von uns erwarten dürfen: eine bedeutungsvolle Tätigkeit in einem stabilen, diversen, erfolgreichen und angesehenen Unternehmen eine attraktive und konkurrenzfähige Vergütung, einschließlich lokaler Sonderzahlungen eine echte Work-Life-Balance flexible Arbeitszeiten sowie betriebliche Regelungen zum Freizeitausgleich ein umfassendes Onboarding mit Unterstützung durch Ihren persönlichen Mentor einen unbefristeten Arbeitsvertrag einen attraktiven, arbeitgeberfinanzierten Pensionsplan hervorragende Fortbildungs- und Entwicklungsmöglichkeiten sowie Unterstützung bei Ihren persönlichen Weiterbildungsplänen kontinuierliche Unterstützung durch Ihren Line Manager, Ihr Team und mehr als 19'000 KollegInnen weltweit Ihre Aufgaben: Unterstützung unserer lokalen Studienteams in allen finanziellen Aspekten klinischer Studien von Studienstart bis zum Close-Out Vertragserstellungen und –verhandlungen mit den Prüfzentren Mitwirkung bei der Erarbeitung von Studienbudgetplänen sowie Umsetzung der jeweiligen Planung in den entsprechenden Finanzsystemen Rechnungsstellung, -bearbeitung und -zahlung sowie fortlaufende Prüfung und Pflege der Finanzdatensysteme Ihr Profil: Berufserfahrung in der Administration / Büroarbeit / Assistenz ist Voraussetzung sicherer Umgang mit MS Office (einschließlich guter MS Excel-Kenntnisse) sehr gute Organisationsfähigkeiten mit einem ausgeprägten Sinn für Details und einem hohen Verantwortungsbewusstsein Erfahrung in Finanzthemen ausgezeichnete Kommunikationsfähigkeiten in verhandlungssicherem Deutsch sowie sehr gute Englischkenntnisse in Wort und Schrift sind ein Muss Fortrea sucht aktiv nach motivierten, lösungsorientierten und kreativen Denkern, die unsere Leidenschaft für die Überwindung von Hindernissen bei klinischen Studien teilen. Unser Ziel ist es, den Entwicklungsprozess zu revolutionieren und sicherzustellen, dass lebensverändernde Ideen und Therapien schnellstmöglich Patienten zur Verfügung gestellt werden. Werden Sie Teil unseres außergewöhnlichen Teams und profitieren Sie von einem kollaborativen Arbeitsumfeld, in dem Ihre persönliche Entwicklung gefördert wird und Sie einen bedeutenden globalen Einfluss ausüben können. Weitere Informationen über Fortrea finden Sie unter www.fortrea.com. Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com. Fortrea is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. For more information about how we collect and store your personal data, please see our Privacy Statement. Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide. As a member of Fortrea’s Global Talent Network, you'll: Be the first to know about exciting opportunities that align with your career interests. Stay informed about the latest trends and developments in the clinical research industry. Be invited to exclusive events and meet with Fortrea leaders to learn more about our company and culture. To stay up-to-date on the latest news, follow us on LinkedIn, Facebook and Twitter.Über das Unternehmen:MUN Fortrea Germany GmbH

DEINE ROLLEJährlich verdoppelt sich die Menge der gesammelten medizinisch relevanten Daten, ohne dass die Arbeitsabläufe und die verwendete Software damit schritthalten kann.Das führt zu großen Herausforderungen für das Gesundheitswesen: Hohe Arbeitsbelastung durch unangepasste Prozesse und suboptimale Behandlung, weil das in den Daten enthaltene Wissen nur unzureichend für die Diagnose und Behandlung genutzt werden kann.Bei RAYLYTIC trägst Du zur Entwicklung von lebensverändernden Therapien bei, indem du Lösungen entwickelst, die Medizinprodukteherstellern und Ärzten helfen, Daten in bestmögliche Outcomes für Patienten umzuwandeln. Wir sind derzeit auf der Suche nach einem/einer Clinical Trial Assistant (w/m/d)  Deine Aufgaben: Du arbeitest eng mit unseren Clinical Trial Manager*innenzusammen und unterstützt diese tatkräftig bei Routineaufgaben (z.B. Vorbereitung von Studienunterlagen, Synchronisation mit internen Tools und Sharepoints). Für unsere Kund*innenerstellst und modifizierst Du Studien in unserer UNITY Plattform und stehst bei kundenspezifischen Rückfragen als kompetente Ansprechperson zur Verfügung. Du bist im Speziellen für zahlreiche Prozesse in der Bilddatenanalyse (mit-)verantwortlich: Du evaluierst radiologische Aufnahmen, führst digitale Vermessungen durch und erstellst Validierungsbilder zur Qualitätssicherung. Du implementierst und bearbeitest Studienfragebögen und unterstützt beim Thema Studienvalidierung. Deine Arbeit und Erkenntnisse dokumentierst Du gewissenhaft für das Team. DEIN PROFILDu besitzt ein abgeschlossenes Bachelorstudium im MINT-Bereich, beispielsweise in einer der folgenden Fachrichtungen: Gesundheitsmanagement/-ökonomie/-wissenschaften o.Ä.Alternativ besitzt Du eine abgeschlossene Ausbildung in der Dokumentenassistenz/medizinischen Dokumentation oder in einem Gesundheitsfachberuf.Du bringst eine ausgeprägte IT-Affinität mit, arbeitest Dich schnell in neue Anwendungen ein und beherrscht MS Office sicher.Zudem bist Du kommunikationsstark, verlässlich und bringst eine proaktive Denk- und Handlungsweise mit. Mit dieser unschlagbaren Kombination bist Du die perfekte Ergänzung für unser bestehendes Team.Sehr gute Deutsch- und Englischkenntnisse runden Dein Profil ab.Ein Plus für uns:Erste Berufserfahrung in einer vergleichbaren Rolle.Ggf. hast Du bereits erste Erfahrung bezüglich der folgenden Regularien: EU MDR 2017/745, ISO 14155:2020, EU Regulation 536/2014, ICH-GCP.WER WIR SIND UND WAS FÜR DICH DRIN ISTUnser Ziel ist es, Patienten und Patientinnen zu besseren Leben zu verhelfen, egal ob sie uns nah am Herzen oder auf der anderen Seite der Welt sind. Wir erreichen dies, indem wir einen Arbeitsplatz mit folgenden Werten kultivieren: Teamwork: Jeder Mitarbeitende bei RAYLYTIC arbeitet hochprofessionell und erbringt damit einen wichtigen Beitrag zum Unternehmenserfolg. Aber nur gemeinsam sind wir ein starkes, internationales Team, das eine Kultur der Gleichberechtigung und Diversität lebt und Herausforderungen annimmt, die das Unternehmen auf die nächste Ebene bringt. Mit lebendigen Teamevents und After-Work-Aktivitäten wie Picknicks und Tischtennis fördern wir dieses Gemeinschaftsgefühl und feiern das Miteinander.  Flexibilität: Wir arbeiten agil und lösungsorientiert - egal ob remote oder aus unserem Büro in der Leipziger Innenstadt. Dank hybrider Arbeitsatmosphäre und bester technischer Ausstattung erreichen wir den optimalen Wissenstransfer mit einem hohen Maß an Selbstbestimmung, auch in Bezug auf die flexible Arbeitszeitgestaltung.  Purpose: Wir sind alle aus dem gleichen Grund hier: Wir wollen Leben retten und die Patientenversorgung durch automatisierte, KI-basierte Technologien nachhaltig verbessern. Das ist unser Ausgangspunkt für jedes Gespräch, jedes Projekt und jede gemeinsame Leistung. Wachstum: Vom Start-Up zum Scale-Up, wir wachsen. Dafür bekommt jeder von uns das Vertrauen und den Spielraum, sich auszuprobieren, zu lernen und sich weiter, auch in neue Richtungen entwickeln zu können, beruflich wie auch persönlich. Wir glauben, dass gesundes Wachstum nicht nur das Ergebnis passionierter Bemühungen ist, sondern auch der Förderung deiner einzigartigen Talente und Potenziale.   Transparenz: Offene Kommunikation und konstruktives Feedback sind Teil unserer DNA. Hybride Teams mit flachen Hierarchien bedeuten, dass dein Einfluss unternehmensweit zu spüren ist. Bei RAYLYTIC wirst du das von Anfang an durch kurze Entscheidungswege und regelmäßige, teamübergreifende Einblicke erleben. Ambition: Wir bestehen darauf, dass wir in der Lage sind, branchenveränderndes Wissen und Instrumente zu entwickeln und dadurch die größten Herausforderungen im Gesundheitswesen zu lösen. Damit unser Impact so groß wie möglich ist, ist es unser Ziel uns als Branchen- und Meinungsführer zu etablieren. Was bedeutet das für dich? Du wirst Teil eines dynamischen Unternehmens sein, dass schnell nach vorn geht und in dem du aktiv unseren Erfolg mitgestalten kannst.     Bewirb dich mit dem Link unten oder kontaktiere unser Recruitment-Team persönlich bei ********** Als Unternehmen, in dem der Mensch im Mittelpunkt steht, garantieren wir ein faires und transparentes Verfahren, unabhängig von Geschlecht, ethnischer und sozialer Herkunft, Religion/Weltanschauung, Behinderung, Alter und sexueller Orientierung. Mit mehr als 10 Nationalitäten und einem ausgewogenen Verhältnis von Männern und Frauen sind wir stolz darauf, uns als vielfältig und integrativ zu bezeichnen.   Liebe Personalvermittlungsagenturen,  wir konnten in der Vergangenheit ausnahmslos alle Stellen mit hochqualifizierten Kandidaten besetzen.​ Bitte sehen ​sie von unaufgeforderten Angeboten und Nachfragen dazu ab - vielen Dank!Über unsAngesichts der rasanten Zunahme digital gespeicherter medizinischer Informationen fehlt es zunehmend an Werkzeugen, um diese Informationen in Form von Wissen zugänglich zu machen und für Diagnosen und individuelle Behandlungsentscheidungen zu nutzen. Wir kooperieren mit Ärzten, Medizinprodukteherstellern und der Life-Sciences-Industrie, um mit Hilfe unserer Software klinische Studien zu automatisieren und medizinische Informationen aus der Routineversorgung in nutzbares Wissen umzuwandeln. Dieser Ansatz zielt darauf ab, Ärzten, Patienten und Herstellern medizinischer Produkte gleichermaßen zu dienen.Wenn Du in einem wachsenden, aber dennoch familiären Startup etwas bewegen möchtest und Dich der Gesundheitssektor fasziniert: Werde Teil unseres Teams und helfe mit, die Medizin und die verwendeten Produkte zu verbessern! Zum Wohle von uns allen, einschließlich Dir selbst und Deiner Familie!Über das Unternehmen:Raylytic GmbH

Location: Baden-Württemberg Germany - Site-basedSchedule: Freelance - 0.5 FTE   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 Clinical Study Nurse to join one of our clients.   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.     Main Job Tasks and Responsibilities: Assists project teams with study-specific documentation as appropriate.Completion of Case Report Forms (CRFs/eCRFs) and Data Clarification Forms (DCFs).Tracking and Quality Control, maintaining drug accountability records, completion of site status reports.Ensures that review source documents e.g. laboratory reports are reviewed and signed by The Investigator.Understand ICH GCP, relevant regulations, and site SOPs.The maintenance of the study files and the databases for the project.Co-coordinates ordering/dispatch and tracking of trial materials.Assists project teams with trial progress tracking and updating distribution tasks by updating the Clinical Trial Management systems.Supports for tracking and safety reporting of study progress.Provides activity reports expenses and timesheets to the Company.Reporting of adverse events (AEs) serious adverse events (SAEs) to all relevant personnel parties.Entering data into the eCRF.Working with the Clinical Research Associate (CRA) to resolve queries.Adhering to the site and study-specific protocol training whilst undertaking visit duties.Maintaining standards of professional competence and current clinical practices under ICG_GCP, EU Clinical Trials Directive EU2001/20EC and German Regulatory Requirements.Completing study visits at the site in line with the study protocol requirements.Provision of excellent standards of service provision following study protocol training and country-specific requirement.Adhering to the Sponsor/Site training and study-specific protocol training, whilst undertaking visit duties.Ensures that all relevant information regarding subjects is recorded, reported and where necessary, acted upon the communicate any changes to the Investigator study team as appropriate.Working at site and Patient Services team and Country Lead to ensure that all aspects of service for assigned groups of subjects are met, through the adherence to study schedules, protocols, and local clinical practice regulations and requirements.Flexible approach to working hours to accommodate the dynamic nature of research visits. Education and Experience:Registered Nurse or Medical Assistant with at least 2 years of post-registration experiencePrevious experience as a Research Nurse or Medical Assistant including a recent (within the last 1 year) ICH-GCP update.Experience in neurology is desirable. Skills Requirement:Measurement of vital signs (i.e., blood pressure, pulse rate, BMI, etc.).Performing ECG.Drawing of blood.Performing the infusion including putting on the infusion tubes and clinical monitoring during/after infusion (following training).Ship blood/laboratory samples to the central lab (training and instructions will be provided).Check questionnaires.Report AEs/SAEs.Liaise with the study team.Enter visit data into eCRF.Database screening.Discuss study information with subjects to aid informed consent.Coordinates all participant visits including inviting study participants, coordinating the visits with the pharmacy, the neuroimaging unit, the local lab, and the home health.Coordinates accounting for travel expenses of study participantsAssists the Principal Investigator (PI) in determining subject eligibility.SAE reporting through safety gateway.Make eCRF entries/corrections/resolve DCFs…Selection and randomisation procedures using IRS.Communicate with IEC.Maintain documentation in the Investigator Site File.Infusion experience essential.Good phlebotomy skills.ECG recording.Managing infusion reactions.Demonstrated organisational skills.Proven flexibility and the ability to work under pressure.Good communication skills.Proficiency in German mandatory, English desirable.Proactive contribution towards the team by being a flexible team player.Ability to work effectively both in a team & independently in a fast-paced environment.Excellent understanding of the clinical processes.Good knowledge of clinical trials, including EU Clinical Trials Directives, Good Clinical Practice for Clinical Trials, and German regulations is desirable, training can be provided.Excellent computer skills required, MS Office proficiency at a minimum. 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:  Study Nurse, Research Nurse, Trial Nurse, MS Office, German, Pharmaceutical, Pharma, CRO, Contract Research Organisation, Outsourced, Sponsor-dedicatedSkills: Nurse, Registered Nurse, Clinical Research Organisation, clinical trials, CRO, MS Office, Pharma, PharmaceuticalLocation: GermanyShare: LinkedIn Facebook Twitter Email