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Überblick über die Statistik des Gehaltsniveaus für "Investigator in Deutschland"

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Überblick über die Statistik des Gehaltsniveaus für "Investigator in Deutschland"

90 000 € Durchschnittliches Monatsgehalt

Durchschnittliches Gehaltsniveau in den letzten 12 Monaten: "Investigator in Deutschland"

Währung: EUR USD Jahr: 2024
Das Balkendiagramm zeigt die Änderung des Gehaltsniveaus in der Investigator Branche in Deutschland

Verteilung des Stellenangebots "Investigator" in Deutschland

Währung: EUR
Wie die Grafik zeigt, in Deutschland gilt Nordrhein-Westfalen als die Region mit der größten Zahl der offenen Stellen in und an zweiter Stelle folgt Berlin. Den dritten Platz nimmt Baden-Württemberg ein.

Ranking der Bundesländer in Deutschland gemäß dem Gehaltsniveau für den Beruf "Investigator"

Währung: EUR
Wie die Grafik zeigt, in Deutschland gilt Nordrhein-Westfalen als die Region mit der größten Zahl der offenen Stellen in und an zweiter Stelle folgt Berlin. Den dritten Platz nimmt Baden-Württemberg ein.

Ranking der ähnlichen Stellenangebote gemäß dem Gehaltsniveau in Deutschland

Währung: EUR
Unter den ähnlichen Berufen in Deutschland gilt Incident Management als der bestbezahlte Beruf. Laut unserer Webseite beträgt das Durchschnittseinkommen 100000 eur. An zweiter Stelle folgt Gaming Commission Investigator mit dem Gehalt von 90000 eur und den dritten Platz nimmt Security Administrator mit dem Gehalt von 80000 eur ein.

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Clinical Project Manager II, Spain - P
TalentSource Life Sciences,
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
Project Manager I, Poland - P
TalentSource Life Sciences,
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 I, 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 Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects.   Join our team and help us deliver clinical trials that will improve patients' lives.                   Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators and coordinating the project team memberOversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical stateManages the budget of the projectParticipates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the SponsorSupervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulationsUndertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levelsMay provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activitiesSupervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projectsMay act as Feasibility Associate (FEA) after appropriate and documented trainingMay prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them Education and Experience:University Degree in scientific, medical, or paramedical disciplinesUp to three 3 years of project management experience in the CRO/Pharmaceutical industryStrong 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
Clinical Research Associate, Poland - P
TalentSource Life Sciences,
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
Clinical Research Associate, Spain - P
TalentSource Life Sciences,
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
Senior Clinical Project Manager, Italy - P
TalentSource Life Sciences,
Location: Italy - Home or office based      Schedule: Permanent, Full-time                 Do you want to join a team that is passionate about making a difference in drug and medical device development?  CROMSOURCE, a growing CRO, is recruiting for a Senior Clinical Project Manager to join their clinical operations team. This is a permanent opportunity in Italy. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                          As a Senior Clinical Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects. Previous experience with respiratory and oncology trials is preferred. A minimum of 3 years of experience with a CRO is needed.           Join our team and help us deliver clinical trials that will improve patients' lives.                               Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators, and coordinating the project team members.Oversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical state.Manages the budget of the project.Participates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the Sponsor.Supervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations.Undertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levels.May provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activities.Supervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projects.May act as Feasibility Associate (FEA) after appropriate and documented training.May prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them. Education and Experience Required:University Degree in scientific, medical, or paramedical disciplines with 3 years of experienceSignificant 3 years of experience in clinical project management in the CRO/pharmaceutical industryExcellent 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 Benefits of Working in Italy:· Meal vouchers· Mobile phone if requested by the Line Manager· Dedicated Line Manager 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 can 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.                                     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 @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.                                        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: Project Manager, Clinical Project Manager, CRO, Clinical Research Organisation, Contract Research Organisation, Clinical, Drugs, Medical Devices, Medical Device, Project Management, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, Respiratory, Oncology, OphthalmologySkills: Clinical Project Manager, Clinical Study Manager, Clinical Trial Manager, Senior Clinical Project Manager, clinical trials, CRO, Medical Devices, Study ManagementLocation: ItalyShare: LinkedIn Facebook Twitter Email
Senior Clinical Research Associate
Allucent, Munich
Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.We are looking for a Senior Clinical Research Associate to join our team in GermanyThe Sr CRA will be responsible for the following tasks: Governs quality standards for trial monitoring activities. Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and Allucent SOPs for monitoring requirements. Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols. Tracks and supervises collection of ongoing study data for purpose of regular project status reporting. Collects and reviews regulatory documents as required. Prepares site visit reports and telephone contact reports. Maintains and updates CTMS in compliance with SOPs and study-specific directives. Acts as Document Owner for collected documents. May participate in the start-up process including preparing Informed Consent forms, developing study documents, EC / CA submissions, and / or site contract management Aims to pro-actively prevent and / or mitigate issues. Resolves site issues, including site recruitment challenges, and determines status for IP shipment. Acts as the main line of communication between the project team and the site staff. Works in collaboration with Allucent Centralized Monitoring Team to evaluate risk-based monitoring activities to facilitate oversight of the study conduct at the sites and prevent issues. Activities are related to but not limited to: Investigational Product supplies, non-IP study supplies, subject eligibility, protocol compliance, facilities, and PI oversight. Identifies potential logistical/practical problems and support Project team to create solutions / contingency plans, with timeframes for resolution. Ensures the continuous maintenance of the Trial Master File and Investigator Site File. Assists the Project Manager (PM) and Clinical Team Leader (CTL) with generation of study specific forms for completion by CRA and Investigators and follow up with the teams to ensure timely completion and submission. Works with Project Manager (PM); Clinical Team Leader (CTL), SSU (Study Start Up) team members or sponsor to ensure authorization of regulatory documents and site contracts. Attends Investigator Meetings (IM) to include organizing and presenting at investigator meetings. and study specific training meetings. May translate, coordinate translations or review completed translations of the essential documents as required. May participates in feasibility and/or site identification activities. Contacts local opinion leaders, medical consultants or specified investigators and identifies sites with the potential for participation. May follow feasibility procedures for documentation of feasibilities performed in collaboration with the Study Start Up Department. Where applicable, identifies the documentation required for review by Regulatory Authorities and Ethical Committees. May prepare Regulatory and Ethics Committee submissions working in conjunction with Study Start Up Department. Ensure written approvals are obtained and distributed appropriately prior to Site Initiation. Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required. May process interim and final payments to Investigators, including preliminary calculations, review and approval from Project Management, liaison with finance, logging trial expenditure, receipts, invoices, and income. Assists the Project Team with the day-to-day management of critical studies as required, including attendance at team meetings. Provides secondary in-house review of CRFs (if required). Support site staff in preparation for study related site audits and inspections. Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions. May be assigned other tasks / activities / responsibilities related to the study execution in the country. May support initiatives in the country, GCO, and / or CTO to contribute to improvements and quality. Must work both independently and in a team environment. Requirements At least three years clinical monitoring experience and/or relevant clinical trial experience. Relevant life science degree / health care / nursing background and/or related degree. Sound knowledge of medical terminology and clinical monitoring process. Strong communication in Local and English language in both written and verbal skills. Strong interpersonal and organizational skills. Ability to translate guidelines, rules and regulations in clear and usable recommendations Representative, outgoing and client focused Ability to work in a fast-paced challenging environment of a growing company In-depth therapeutic and protocol knowledge Ability to perform travel an average of 65%, depending on project needs. In-depth therapeutic and protocol knowledge as provided in previous, or company provided training. Attention to detail. Ability to work independently and to effectively prioritize tasks, establish, and maintain strong working relationships with co-workers, managers, investigators, site personnel and clients. Demonstrated ability to manage multiple projects. Administrative excellence Proficiency with various computer applications such as Word, Excel, and PowerPoint required Demonstrated ability to develop, organize and manage new skills and tasks and mentor colleagues. Ability to manage multiple projects Benefits Comprehensive benefits package Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for fully remote working or hybrid Working Model Leadership and mentoring opportunities Internal growth opportunities and career progression More task variety Financially rewarding internal Employee Referral Program Access to online soft-skills and technical training via GoodHabitz and internal platforms To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes#LI-BL1 Standort Allucent, Munich
Data Fraud Analyst - Loss Prevention Europe
PUMA Europe GmbH, PUMA Way PEG
YOUR MISSION Design, maintain and lead Anti-Fraud Validation. Query, analyse and validate transactional and financial data for instances requiring follow-up by the Loss Prevention team. Design, prepare and distribute the Loss Prevention Reporting Package and any reports that may be required by management. Maintain a central documentation and audit trail of all fraud-related validation rules, including the rationale for validation and change logs where appropriate. Maintain a central fraud and investigation database. Create and maintain documentation relating to Loss Prevention activities for the Loss Prevention manual. Support with the development and maintenance of the investigation manual. Evaluate and analyse data to give recommendations to drive sales and profitability. YOUR TALENT Relevant statistical, system, programming language qualification/certification. Proven experience in fraud prevention, detection, or analysis. Advanced level understanding of SQL and Python data fraud analysis. Advanced level understanding of Excel. Hands-on experience with Power BI. Experience in retail for brick-and-mortar stores. Strong analytical and problem-solving skills. Strong written and verbal communication skills, with the ability to “tell a story” from data. Strong English language skills, German language knowledge is a plus. Audit, Anti-Fraud or Loss Prevention qualification/certification is desirable. SPEED & SPIRIT is what we look for in our candidates, defined by some simple values that inspire us to BE DRIVEN in our performance, BE VIBRANT in our sporting legacy, BE TOGETHER in our team spirit, and BE YOU to let our individual talent and experience shine. Applying for a job at PUMA is easy. Simply click APPLY ONLINE and follow the steps to upload your application. At PUMA, we are in constant pursuit of faster. That extends beyond our support of the fastest athletes in the world. We also work to be fast in how we adapt to and connect with the constantly changing world around us. Through innovative design, iconic footwear and apparel, and authentic partnerships, we aim to always push what’s next in both sport and culture. PUMA supports over 14,000 employees across 120+ countries. The PUMA Group owns the brand PUMA, Cobra Golf and stichd, and is headquartered in Herzogenaurach, Germany.Über das Unternehmen:PUMA Europe GmbH
Clinical Study Nurse, Germany - L
TalentSource Life Sciences, Germany
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
Medical Science Liaison - Hematology (m/f/d) - Baden-Württemberg
582 GlaxoSmithKline GmbH & Co. KG, Field Worker - DEU (Munich)
GSK’s portfolio spans three product areas: vaccines, specialty and general medicines and our focus is to deliver better and faster for patients globally. Our unrivalled vaccine portfolio targets infectious diseases at every stage of life, helping to reduce the burden of disease for hundreds of millions of people. GSK has exceptional capabilities in vaccine science and technologies, including adjuvant/protein and mRNA. In specialty medicines, we are at the forefront of HIV prevention and treatment, and we are building our presence in key therapeutic areas such as oncology and immuno-inflammation. General medicines include our inhaled medicines for asthma and COPD, antibiotics, and medicines for skin diseases. By 2031, we aim to deliver more than £33 billion in annual sales – a step-change in performance and growth which will significantly increase the positive impact we can have on the health of billions of patients around the world. And we’re confident in our future. Our pipeline of 21 vaccines and 43 medicines includes many with potential to be first or best-in-class opportunities for patients. Medical Science Liaison - Hematology (m/f/d) Medical Affairs is a critical bridge between R&D and the commercial organization to ensure that our medicines reaches the appropriate patients. The MSL Manager is a critical role to ensure oncology resource and activities are aligned and deployed to business priorities and patient needs. The function is crucial to build up scientific expertise to provide greater insight and significant external presence. Region: Baden-Württemberg Key Responsibilities This role will provide you the opportunity to lead key activities as follows: Creating and forming measures and programs out of the medical strategy within their designated scope, schedule, and resources Management of all medical affairs activities in the territory Development, implementation and project lead of medical scientific projects Identification and support of relevant study centres and cooperation partners and intensification of scientific dialogues (discussion of latest publications, data and therapies; scientific presentation and moderation of advisory boards / symposiums; …) Acting as a partner of choice and consultant for all external KOL´s and HCP´s Support of clinical research programming across the continuum (Investigator sponsored research, Cooperative Group and Collaborator research, Company Sponsored trials) Partnering within all areas of GMA (e.g. Medical Directors, Medical Communications, Medical Information, Publications, Patient Advocacy) and support as content expert for Clinical Research, Sales, Marketing, Market Access, Patient Advocacy, Communications Qualifications & Skills We are looking for professionals with these required skills to achieve our goals: Accredited doctorate degree in a life-science or basic-science discipline (Pharm.D., D.Sc., D.N.P., Ph.D., or M.D./D.O.) Clear evidence of Oncology experience - preferably within last few years Demonstrated understanding of the European healthcare environment, including knowledge of health technology assessments and market access challenges as well as understanding of Pharmaceutical ethics and governance, of pharmaceutical compliance policies and procedures Expert public speaking and written communication skills Successful and superior influencing skills across all levels of the organization and with external collaborators Problem solving and risk-mitigation skills Fluency in English and German Willingness to travel extensively Preferred Qualifications & Skills If you have the following characteristics, it would be a plus: Demonstrable experience and success in MSL organizations in therapeutic oncology Prior experience with product launches Financial and budget management Find out more: Annual Report 2022 Product Pipeline #EBDE Why Us? GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site. We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.Über das Unternehmen:582 GlaxoSmithKline GmbH & Co. KG
Senior Associate MSL (m/w/d)/Medical Science Liaison (m/w/d) Rare Disease, Region Süd
1025 Amgen GmbH, Germany - Munich
Career Category Medical Affairs Job Description Als Pionier der Biotechnologie erforscht, entwickelt und produziert Amgen innovative Therapien und ist mit ca. 22.000 Mitarbeitern und Niederlassungen in über 100 Ländern überall auf der Welt präsent. Unsere Arzneimittel helfen Millionen von Patienten bei ihrem Kampf gegen schwere Erkrankungen wie z.B. Krebs, Nieren- oder Herz-/ Kreislauferkrankungen. In Deutschland wird Amgen durch einen Forschungsstandort und einen Vertriebsstandort vertreten. Beide Standorte befinden sich in München. Diese Ausschreibung betrifft den Vertriebsstandort in der Riesstraße. Senior Associate Medical Science Liaison (m/w/d)/Medical Science Liaison (m/w/d) Rare Disease, Region Süd AUFGABENSTELLUNG: Repräsentant:in für die medizinische Abteilung innerhalb der oben genannten Regionen Identifizierung der wissenschaftlichen Experten und Intensivierung bestehender Kontakte Kooperation mit der Abteilung Klinische Forschung bei der Auswahl geeigneter Prüfzentren für klinische Studien und medizinisch-wissenschaftliche Betreuung in deren Verlauf Teilnahme an Studientreffen, nationalen und internationalen Kongressen mit anschließender Berichterstattung über aktuelle Entwicklungen in und Erkenntnissen zu spezifischen Indikationsgebieten Planung und Durchführung medizinisch-wissenschaftlicher Aktivitäten wie Vorträge, regionale Advisory Boards und Fortbildungen im zugewiesenen Gebiet sowie gebietsübergreifend Ansprechpartner:in für Investigator Sponsored Studies in der Region Beobachtung des Wettbewerbs im Therapiebereich Rare Disease sowie proaktive Zusammenarbeit mit den regionalen funktionsübergreifenden Teams Entwicklung auf die Kundenbedürfnisse zugeschnittener Omnichannel-Ansätze und deren Umsetzung im eigenen Arbeitsbereich VORAUSSETZUNGEN: Abgeschlossenes medizinisches oder naturwissenschaftliches Hochschulstudium, idealerweise mit Promotion Idealerweise mindestens 3 Jahre Erfahrung im Bereich Medical Affairs oder Medical Science sowie solide Erfahrung in der klinischen Entwicklung von Arzneimitteln zur Behandlung seltener Krankheiten wünschenswert Gute Produkt- und Literaturkenntnisse sowie solides medizinisches Basiswissen und Erfahrung im Fachgebiet sind ein Plus Erfahrung in der Planung und Initiierung von Projekten bzw. bei der Durchführung von Studien wünschenswert Gute EDV-Kenntnisse (MS-Office) sowie sehr gute Deutsch- und sehr gute Englischkenntnisse, in Wort und Schrift Starke Kundenorientierung, wissenschaftliche/bereichsübergreifende Denkweise Ausgeprägte Kommunikations-, Präsentations- und Verhandlungsstärke, sicheres Auftreten, Durchsetzungsvermögen, Teamplayer Hohe Reisebereitschaft Ansprechpartnerin: Andreia Campos (Human Resources), Tel: +49 (0)89 - 149096-1109 AMGEN BIETET UNTER ANDEREM: In unserem internationalen und dynamischen Arbeitsumfeld mit flachen Hierarchien können Sie täglich Ihre persönlichen und sozialen Kompetenzen weiter entwickeln. Unser Arbeitsstil ist geprägt von Wertschätzung, Offenheit, Teamgeist und dem Willen zum gemeinsamen Erfolg. Als Teil des Teams von Amgen profitieren Sie u.a. von einem großen Angebot an Weiterbildungsmöglichkeiten, betrieblicher Altersversorgung und vergünstigten Konditionen bei Kooperationspartnern aus dem Fitnessbereich. MÖCHTEN SIE SICH BEWERBEN? Ihre aussagekräftigen Bewerbungsunterlagen (Anschreiben, Lebenslauf, Zeugnisse) übermitteln Sie bitte ausschließlich über unser Online-Karriereportalauf www.amgen.de. Auch für weitere Informationen zu Amgen laden wir Sie herzlich auf unsere Homepage ein. . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgenÜber das Unternehmen:1025 Amgen GmbH
Senior Associate MSL (m/w/d)/Medical Science Liaison (m/w/d) Rare Disease, Region Nord
1025 Amgen GmbH, Germany - Munich
Career Category Medical Affairs Job Description Als Pionier der Biotechnologie erforscht, entwickelt und produziert Amgen innovative Therapien und ist mit ca. 22.000 Mitarbeitern und Niederlassungen in über 100 Ländern überall auf der Welt präsent. Unsere Arzneimittel helfen Millionen von Patienten bei ihrem Kampf gegen schwere Erkrankungen wie z.B. Krebs, Nieren- oder Herz-/ Kreislauferkrankungen. In Deutschland wird Amgen durch einen Forschungsstandort und einen Vertriebsstandort vertreten. Beide Standorte befinden sich in München. Diese Ausschreibung betrifft den Vertriebsstandort in der Riesstraße. Senior Associate Medical Science Liaison (m/w/d)/Medical Science Liaison (m/w/d) Rare Disease, Region Nord AUFGABENSTELLUNG: Repräsentant:in für die medizinische Abteilung innerhalb der oben genannten Regionen Identifizierung der wissenschaftlichen Experten und Intensivierung bestehender Kontakte Kooperation mit der Abteilung Klinische Forschung bei der Auswahl geeigneter Prüfzentren für klinische Studien und medizinisch-wissenschaftliche Betreuung in deren Verlauf Teilnahme an Studientreffen, nationalen und internationalen Kongressen mit anschließender Berichterstattung über aktuelle Entwicklungen in und Erkenntnissen zu spezifischen Indikationsgebieten Planung und Durchführung medizinisch-wissenschaftlicher Aktivitäten wie Vorträge, regionale Advisory Boards und Fortbildungen im zugewiesenen Gebiet sowie gebietsübergreifend Ansprechpartner:in für Investigator Sponsored Studies in der Region Beobachtung des Wettbewerbs im Therapiebereich Rare Disease sowie proaktive Zusammenarbeit mit den regionalen funktionsübergreifenden Teams Entwicklung auf die Kundenbedürfnisse zugeschnittener Omnichannel-Ansätze und deren Umsetzung im eigenen Arbeitsbereich VORAUSSETZUNGEN: Abgeschlossenes medizinisches oder naturwissenschaftliches Hochschulstudium, idealerweise mit Promotion Idealerweise mindestens 3 Jahre Erfahrung im Bereich Medical Affairs oder Medical Science sowie solide Erfahrung in der klinischen Entwicklung von Arzneimitteln zur Behandlung seltener Krankheiten wünschenswert Gute Produkt- und Literaturkenntnisse sowie solides medizinisches Basiswissen und Erfahrung im Fachgebiet sind ein Plus Erfahrung in der Planung und Initiierung von Projekten bzw. bei der Durchführung von Studien wünschenswert Gute EDV-Kenntnisse (MS-Office) sowie sehr gute Deutsch- und sehr gute Englischkenntnisse, in Wort und Schrift Starke Kundenorientierung, wissenschaftliche/bereichsübergreifende Denkweise Ausgeprägte Kommunikations-, Präsentations- und Verhandlungsstärke, sicheres Auftreten, Durchsetzungsvermögen, Teamplayer Hohe Reisebereitschaft Ansprechpartnerin: Andreia Campos (Human Resources), Tel: +49 (0)89 - 149096-1109 AMGEN BIETET UNTER ANDEREM: In unserem internationalen und dynamischen Arbeitsumfeld mit flachen Hierarchien können Sie täglich Ihre persönlichen und sozialen Kompetenzen weiter entwickeln. Unser Arbeitsstil ist geprägt von Wertschätzung, Offenheit, Teamgeist und dem Willen zum gemeinsamen Erfolg. Als Teil des Teams von Amgen profitieren Sie u.a. von einem großen Angebot an Weiterbildungsmöglichkeiten, betrieblicher Altersversorgung und vergünstigten Konditionen bei Kooperationspartnern aus dem Fitnessbereich. MÖCHTEN SIE SICH BEWERBEN? Ihre aussagekräftigen Bewerbungsunterlagen (Anschreiben, Lebenslauf, Zeugnisse) übermitteln Sie bitte ausschließlich über unser Online-Karriereportalauf www.amgen.de. Auch für weitere Informationen zu Amgen laden wir Sie herzlich auf unsere Homepage ein. . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgenÜber das Unternehmen:1025 Amgen GmbH
International Medical Science Liaison
PreventionGenetics, Düsseldorf
Help us change livesAt Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.Company OverviewExact Sciences is dedicated to delivering patient critical answers across the cancer journey from early detection to treatment decision making. With a strong focus on people and an empathetic spirit, which fuels the company’s culture, driving them to create and deliver solutions rooted in the needs of patients, providers, and families.From earlier cancer detection to treatment guidance and monitoring, Exact Sciences are helping people get the answers they need to make more informed decisions across the cancer continuum. With a leading portfolio of products for earlier detection and treatment guidance, they help people face the most challenging decisions with confidence with a dedication to continuously innovate, combining scientific rigor with an open-minded approach to deliver the next big thing.Exact Sciences is continuously expanding the pipeline with the aim of tackling a wider array of cancer tests through the following measures:Expanding the Oncotype IQ platform to include liquid and tissue-based tests, all with the goal of making cancer care smarter.Adapting biomarker-based technologies create a liquid biopsy capable of detecting cancers and precancers from a blood sample.Using their proven multi-marker approach to achieve analytical sensitivity needed to discriminate between normal and cancerous samples.Collaborating with world-class clinicians and scientists at Mayo Clinic to identify biomarkers associated with the 15 deadliest cancers.Building a cancer detection platform upon learnings from the development of Cologuard (commercially available in the US only).By 2020, Oncotype DX will have been used to guide treatment decisions for more than 1 million cancer patients worldwide in breast, prostate and colon cancer.In July 2019 Exact Sciences acquired Genomic Health, a genetic cancer detection company based in Redwood City, California, for USD 2.8 billion, creating the leading global cancer diagnostics company.In 2020 Exact Sciences acquired Thrive Earlier Detection Corp., a Massachusetts-based healthcare company, in a multi-billion-dollar deal, and Base Genomics, which has technology for DNA methylation analysis.In February 2021 Exact Sciences announced the acquisition of Ashion Analytics, LLC (Ashion) from The Translational Genomics Research Institute (TGen), an affiliate of City of Hope. Ashion is a CLIA-certified and CAP-accredited sequencing lab based in Phoenix, Arizona with the genomics testing capabilities necessary to address the increasingly complex needs of clinical, academic, and biopharma customers focused on precision cancer treatments.The company is based in the United States, with International headquarters in Zug, Switzerland. Position SummaryRepresenting the medical function, the MSL will act as a medical/clinical education liaison to external and internal stakeholders, while supporting commercial business and reimbursement objectives for the portfolio of products, most notably for breast and colorectal cancers. This role will engage with customers and colleagues across medical affairs and commercial groups to provide medical and scientific support for our on-market as well as help launch newer products into the international region.Near term business objectives include supporting growth of the Oncotype DX Breast Recurrence Score assay by providing medical information and education through scientific exchange in a fair-balanced manner to Medical Oncology, Surgeons, and Pathology Key Opinion Leaders as well as other healthcare professionals. In addition, the role supports the company’s R&D and investigator-initiated studies in the development and commercialization of genomic assays that lead to improved treatment decisions for oncology patients.To be an effective business partner MSLs develop and maintain outstanding knowledge of Exact Sciences products, competitor products, and other diagnostic options within therapeutic areas. MSLs must also maintain an in-depth understanding of the medical strategy and broader Exact Sciences strategy to ensure their own activities are coordinated and aligned. MSLs must be professionals with integrity and scientific creditability to interact with thought leaders, government health authorities, and medical centers of excellence.This position is based in Germany.Essential DutiesInclude, but are not limited to, the following:Inline Product & Team SupportDeliver education of the broad healthcare provider (HCP) community, such as key opinion leaders (KOL’s), oncologists, pathologists, surgeons, nurses, and payors regarding Exact Sciences products as permissible by local laws and regulations.Serves as external, credible scientific expert on disease area and Exact Sciences products at HCP field meetings, key medical and scientific conferences, advisory boards, clinical investigator meetings and patient advocacy group meetings.Responds to unsolicited requests for medical information on Exact Sciences products in a credible, balanced/objective manner.Participate in the development and execution of a KOL outreach plans.Identify and map KOL, other stakeholder, key accounts as well as patient referral patterns and pathways.Maintain and develop synergistic relationships with KOLs to expand research, advisory, and educational partnership opportunities.Support medical-marketing initiatives, such as conference planning and support, medical education content development, faculty speaker training, sales training, reimbursement initiatives.Work with medical directors to take complex medical messages and position them to enable clear and concise understanding by both external audiences and partners within Exact Sciences.Stay abreast of new clinical developments, publications, and market trends to be a conduit for the greater medical team and other internal teams for review of these developments.Assist with set up and delivery of advisory boards, speaker trainings, and external payor reviews, as needed.Support preparation and presentation of medical review slides and materials at national sales meetings, pre-conference meetings, and field sales conference calls.Attend, develop summaries of, and present key medical findings from scientific congresses.Gather and interpret new clinical data from conferences and literature, as well as competitive intelligence, and report back on findings to medical affairs and marketing stakeholders.Pipeline & Clinical Trials SupportIdentify physicians currently managing patients with breast and colorectal cancer and cultivate a network of experts at academic and community centers to identify new trial sites and/or drive patient referrals and rapid enrolment.Delivers medical / scientific training to clinical study sites and provide input to key internal stakeholders on training materials for clinical trials, products in development, therapeutic areas, and disease state as outlined by the trial sponsor.Establishes and maintain strong working relationships with Principal Investigators (PIs) and clinical trial sites to support the enrollment and conduct of Exact Sciences clinical studies. Facilitate escalation of investigator questions/concerns, recruitment/retention initiatives and clinical site & investigators meetings as it relates to recruitment strategies.Minimum QualificationsAdvanced degree in clinical specialty (PharmD, PhD, MD) with clinical experience.3-5+ years’ experience as an MSL/CTL or senior clinical development role.3+ years Oncology experience required.3+ years of experience in pharmaceutical industry with knowledge of clinical research design and conduct.Preferred QualificationsExperience in Diagnostics or Biotech industry is a plus.SkillsExcellent oral, written and presentation communication skills. Excellent English, multiple languages preferred.Proficient use of Microsoft Office Suite and other IT systems.Experience with VEEVA systems is a plus.Ability to independently deliver quality results in a timely manner.Ability to work as part of a team.Cultural ImpactHighest integrity and ethical behavior.Mutual respect for colleagues.Collaborative within teams, uses resources carefully and can build a great place to work and grow.Ability to interact within culturally diverse teams.Business acumen and innovative mindset. Ability to manage though complexity and ambiguity, while focusing on the end goal.Discretion with sensitive and confidential information.OtherAbility to travel 60-70% % of working time away from work location, may include overnight/weekend travel.#LI-TK1Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, email E-Mail anzeigen. We’ll work with you to meet your accessibility needs.Not ready to apply? Join our talent community and stay up to date on what’s new at Exact Sciences. Standort PreventionGenetics, Düsseldorf
International Medical Science Liaison
Genomic Health, Inc., Germany
Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Company Overview Exact Sciences is dedicated to delivering patient critical answers across the cancer journey from early detection to treatment decision making. With a strong focus on people and an empathetic spirit, which fuels the company’s culture, driving them to create and deliver solutions rooted in the needs of patients, providers, and families. From earlier cancer detection to treatment guidance and monitoring, Exact Sciences are helping people get the answers they need to make more informed decisions across the cancer continuum. With a leading portfolio of products for earlier detection and treatment guidance, they help people face the most challenging decisions with confidence with a dedication to continuously innovate, combining scientific rigor with an open-minded approach to deliver the next big thing. Exact Sciences is continuously expanding the pipeline with the aim of tackling a wider array of cancer tests through the following measures: Expanding the Oncotype IQ platform to include liquid and tissue-based tests, all with the goal of making cancer care smarter. Adapting biomarker-based technologies create a liquid biopsy capable of detecting cancers and precancers from a blood sample. Using their proven multi-marker approach to achieve analytical sensitivity needed to discriminate between normal and cancerous samples. Collaborating with world-class clinicians and scientists at Mayo Clinic to identify biomarkers associated with the 15 deadliest cancers. Building a cancer detection platform upon learnings from the development of Cologuard (commercially available in the US only). By 2020, Oncotype DX will have been used to guide treatment decisions for more than 1 million cancer patients worldwide in breast, prostate and colon cancer. In July 2019 Exact Sciences acquired Genomic Health, a genetic cancer detection company based in Redwood City, California, for USD 2.8 billion, creating the leading global cancer diagnostics company. In 2020 Exact Sciences acquired Thrive Earlier Detection Corp., a Massachusetts-based healthcare company, in a multi-billion-dollar deal, and Base Genomics, which has technology for DNA methylation analysis. In February 2021 Exact Sciences announced the acquisition of Ashion Analytics, LLC (Ashion) from The Translational Genomics Research Institute (TGen), an affiliate of City of Hope. Ashion is a CLIA-certified and CAP-accredited sequencing lab based in Phoenix, Arizona with the genomics testing capabilities necessary to address the increasingly complex needs of clinical, academic, and biopharma customers focused on precision cancer treatments. The company is based in the United States, with International headquarters in Zug, Switzerland. Position Summary Representing the medical function, the MSL will act as a medical/clinical education liaison to external and internal stakeholders, while supporting commercial business and reimbursement objectives for the portfolio of products, most notably for breast and colorectal cancers. This role will engage with customers and colleagues across medical affairs and commercial groups to provide medical and scientific support for our on-market as well as help launch newer products into the international region. Near term business objectives include supporting growth of the Oncotype DX Breast Recurrence Score assay by providing medical information and education through scientific exchange in a fair-balanced manner to Medical Oncology, Surgeons, and Pathology Key Opinion Leaders as well as other healthcare professionals. In addition, the role supports the company’s R&D and investigator-initiated studies in the development and commercialization of genomic assays that lead to improved treatment decisions for oncology patients. To be an effective business partner MSLs develop and maintain outstanding knowledge of Exact Sciences products, competitor products, and other diagnostic options within therapeutic areas. MSLs must also maintain an in-depth understanding of the medical strategy and broader Exact Sciences strategy to ensure their own activities are coordinated and aligned. MSLs must be professionals with integrity and scientific creditability to interact with thought leaders, government health authorities, and medical centers of excellence. This position is based in Germany. Essential Duties Include, but are not limited to, the following: Inline Product & Team Support Deliver education of the broad healthcare provider (HCP) community, such as key opinion leaders (KOL’s), oncologists, pathologists, surgeons, nurses, and payors regarding Exact Sciences products as permissible by local laws and regulations. Serves as external, credible scientific expert on disease area and Exact Sciences products at HCP field meetings, key medical and scientific conferences, advisory boards, clinical investigator meetings and patient advocacy group meetings. Responds to unsolicited requests for medical information on Exact Sciences products in a credible, balanced/objective manner. Participate in the development and execution of a KOL outreach plans. Identify and map KOL, other stakeholder, key accounts as well as patient referral patterns and pathways. Maintain and develop synergistic relationships with KOLs to expand research, advisory, and educational partnership opportunities. Support medical-marketing initiatives, such as conference planning and support, medical education content development, faculty speaker training, sales training, reimbursement initiatives. Work with medical directors to take complex medical messages and position them to enable clear and concise understanding by both external audiences and partners within Exact Sciences. Stay abreast of new clinical developments, publications, and market trends to be a conduit for the greater medical team and other internal teams for review of these developments. Assist with set up and delivery of advisory boards, speaker trainings, and external payor reviews, as needed. Support preparation and presentation of medical review slides and materials at national sales meetings, pre-conference meetings, and field sales conference calls. Attend, develop summaries of, and present key medical findings from scientific congresses. Gather and interpret new clinical data from conferences and literature, as well as competitive intelligence, and report back on findings to medical affairs and marketing stakeholders. Pipeline & Clinical Trials Support Identify physicians currently managing patients with breast and colorectal cancer and cultivate a network of experts at academic and community centers to identify new trial sites and/or drive patient referrals and rapid enrolment. Delivers medical / scientific training to clinical study sites and provide input to key internal stakeholders on training materials for clinical trials, products in development, therapeutic areas, and disease state as outlined by the trial sponsor. Establishes and maintain strong working relationships with Principal Investigators (PIs) and clinical trial sites to support the enrollment and conduct of Exact Sciences clinical studies. Facilitate escalation of investigator questions/concerns, recruitment/retention initiatives and clinical site & investigators meetings as it relates to recruitment strategies. Minimum Qualifications Advanced degree in clinical specialty (PharmD, PhD, MD) with clinical experience. 3-5+ years’ experience as an MSL/CTL or senior clinical development role. 3+ years Oncology experience required. 3+ years of experience in pharmaceutical industry with knowledge of clinical research design and conduct. Preferred Qualifications Experience in Diagnostics or Biotech industry is a plus. Skills Excellent oral, written and presentation communication skills. Excellent English, multiple languages preferred. Proficient use of Microsoft Office Suite and other IT systems. Experience with VEEVA systems is a plus. Ability to independently deliver quality results in a timely manner. Ability to work as part of a team. Cultural Impact Highest integrity and ethical behavior. Mutual respect for colleagues. Collaborative within teams, uses resources carefully and can build a great place to work and grow. Ability to interact within culturally diverse teams. Business acumen and innovative mindset. Ability to manage though complexity and ambiguity, while focusing on the end goal. Discretion with sensitive and confidential information. Other Ability to travel 60-70% % of working time away from work location, may include overnight/weekend travel. #LI-TK1 Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, email **********. We’ll work with you to meet your accessibility needs. Not ready to apply? Join our talent community and stay up to date on what’s new at Exact Sciences. We are Exact Sciences, and we're changing lives together through earlier detection and smarter answers. https://vimeo.com/660680929Über das Unternehmen:Genomic Health, Inc.
(Senior) Manager* Clinical Trials
BioNTech, Mainz, RP
Open for hire at one of the following locations – Mainz Goldgrube, Cambridge, Gaithersburg, London. - Job ID: 6298 Become a member of the BioNTech Family!As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history. We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives. (Senior) Manager* Clinical Trials Your main responsibilities are: Independently leading a cross functional team for study execution for one or several studies. May also support a Assoc. Director on this activity or may be responsible for a smaller programResponsible for defining and implementing the study quality standards and study objectives as agreed with the program teamResponsible for Vendor oversight and issue resolution/escalation for the responsible studiesResponsible for ensuring study timelines are per plan or mitigations are introduced to limit timeline shiftsWork with cross functional team and the CRO to prepare and compile documents for ethics committee and health authority submission and study plansPlanning, review, and conduct of training sessions relevant to the studies as well as team and investigator meetings/PSVs/SIVsDelegation and supervision of one or more clinical trial specialists assigned to the studiesPreparation and presentation of Study status, risks, and mitigations to management and the cross functional teams What you have to offer: A bachelor’s degree in the life sciences or a university degree with experience in a health professionMinimum 5 years of professional experience as a Clinical Study Manager, CRA/Clinical Monitor or in a similar function, with at least 3 years managing a cross functional team for study execution (Phase 1-3)Experienced in managing vaccine studies is a plusExperienced in managing studies in Sub-Saharan Africa is a plusVery good knowledge of relevant laws and regulations (e.g. ICH GCP guideline)Proactive, independent way of working as well as excellent communication and organizational skills Benefits for youBioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.Click here to find out more about what we do, the careers we offer and also the benefits we provide.Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law. Have we kindled your pioneering spirit? This vacancy is to be hired at one of the following locations – Mainz Goldgrube, Cambridge, Gaithersburg, London. Apply now for your preferred job and location through our careers site.*BioNTech does not differentiate on the basis of race, colour, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, veteran status, genetic information, or any other characteristic protected by applicable law. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!Über das Unternehmen:BioNTech
Clinical Trial Coordinator (m/f/d)
Johnson and Johnson, Aachen, Nordrhein-Westfalen
Abiomed is an innovative medical device business with an inspiring mission "Patients First" and a unique guiding company principle "Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world with corporate headquarters in Danvers, USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan, and Singapore. Abiomed is part of Johnson & Johnson MedTech.Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.Clinical Trial CoordinatorThe Clinical Trial Coordinator (CTC) supports Clinical Project and Program Managers in planning and coordinating activities in all aspects of clinical trial operations. This position requires appropriate interpretation of significant policies and procedures. It involves interaction with internal and external customers and partners, and must operate with a high degree of discretion, as the role involves handling information of a confidential and critical nature.Main tasks and responsibilities:Plan, coordinate, and arrange study communications and meetings on and off-site with both internal and external attendeesPrepare all necessary documents for the evaluation of new proposals and coordinate the decision process of new AR or ISS projectsManage the grant application platform which maintains all necessary documents and the communication with PIsSet up, update, maintain and close Trial Master Files. Assure currency and accuracy of required clinical trials documents Maintain project-specific regulatory document inventory systems which include a precise quality check (QC) process when documents are receivedCommunicate with investigator sites on collection of regulatory documentsCreate study materials, including newsletters, study updates, etc. under the direction of a Scientist or Clinical Program ManagerSource and distribute study suppliesInteract with Finance departments to support invoice processingInteract with the Sales and Customer service department to support and coordinate external needs and internal processes.Under guidance of Clinical Operations management, interact with internal stakeholders and external clients to coordinate the accomplishment of business needsRequirements:BS degree or BS degreeRelevant clinical or basic research experience working at an Investigator Site, Sponsor or Clinical Research OrganizationFamiliarity of clinical trial operations, ICH, GCP Guidelines Good working experience in a team environment across multi-functional areasHighly organized, self-motivated, detail-oriented, proactive, and accurateAbility to work with urgency and thrive in a high-energy, fast-paced environmentDemonstrate excellent communication, verbal and written, and interpersonal skillsFluent in written and spoken English and GermanDemonstrate proficiency in MS Office Suite: Word, PowerPoint, Excel, Project ABIOMED is an Equal Employment Opportunity employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, disability or national origin. Über das Unternehmen:Johnson and Johnson
Qualitätsingenieur Medizintechnik - Qualitätssysteme, CAPAs (m/w/d)
Hu-Friedy Mfg. Co., LLC., Villingen-Schwenningen
Über HuFriedyGroup:Die HuFriedyGroup ist mit insgesamt über 177 Jahren Erfahrung in der Dentalindustrie weltweit führend in den Bereichen Infektionsprävention, Instrumentenherstellung und Wiederaufbereitung von Instrumenten. Die HuFriedyGroup hilft Zahnärzten dabei, „Best in Practice“ zu sein, indem sie einen geschlossenen „Circle of Protection“ in der Praxis bereitstellt und erstklassige Produkte, Dienstleistungen, Weiterbildungen und Netzwerke bietet, die zu erstklassigen klinischen Leistungen und Ergebnissen führen und auch die Sicherheit für Behandler und Patienten gewährleistet.Als Teil der STERIS Gruppe, mit mehr als 18.000 Mitarbeitenden weltweit, bieten wir zusammen umfassende Produkte und Dienstleistungen für die Gesundheitsbranche. Unsere Aufgabe bei STERIS ist es, unseren Kunden dabei zu helfen, die Welt gesünder und sicherer zu machen.Werde Teil von STERIS! Für unser starkes Team am Standort Emmingen-Liptingen suchen wir eine analytische, kommunikationsstarke Persönlichkeit alsQualitätsingenieur (m/w/d) MedizintechnikDu verantwortest die Aufrechterhaltung, (Weiter-) Entwicklung und kontinuierliche Verbesserung (KVP) unserer Qualitätssysteme gemäß ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR etc. zur Steigerung unserer Produkt- und Servicequalität. Parallel dazu kümmerst Du Dich um die Qualifizierung von Produktionsanlagen und die Prozessvalidierung für drei Standorte (Deutschland, Griechenland, Italien) und arbeitest an Untersuchungen von Beschwerden / CAPAs und der Qualitätsoptimierung bei Lieferanten mit.Deine Aufgaben:Entwickeln und Umsetzen statistisch valider Stichproben- und Versuchspläne, Machbarkeitsstudien, SPC und TrendanalysenDurchführen von Audits des Qualitätssystems, Prüfen gesammelter Daten sowie Erheben statistischer Analysen rund um qualitätssteigernde Prozess- und ProduktanpassungenMonitoring und Bericht der Leistungskennzahlen sowie Initiieren von und / oder Teilnahme an Prozess- und ProduktkorrekturmaßnahmenErstellen, Dokumentieren und Aktualisieren von Arbeitsanweisungen inklusive Unterweisung der Teams in puncto Qualitätsgrundsätze, Korrekturmaßnahmen und gültige statistische TechnikenEnge interdisziplinäre Zusammenarbeit mit verschiedenen Bereichen bei qualitätsbezogenen FragenAufrechterhaltung der Produktintegrität und -qualität, z. B. durch die Bewertung und Disposition nicht konformer Materialien Dein Profil: Technisches oder betriebswirtschaftliches Studium, gern mit relevanten Weiterbildungen rund um QS und QMErfahrung im Projekt- und / oder Qualitätsmanagement, sicherer Umgang mit grundlegenden Qualitätstechniken und -planungen sowie Kenntnisse gültiger Normen, wie ISO 9001 und IATF 16949Gutes Deutsch und Englisch (Wort / Schrift) sowie routinierter Umgang mit MS Office20 % ReisebereitschaftWir bieten Dir:Sicherer Job im KundenserviceEinen unbefristeten und langfristigen Arbeitsplatz in einem globalen UnternehmenAttraktive Vergütung und GleitzeitJährlicher erfolgsbasierter Bonus30 Urlaubstage (plus Sonderurlaubstage)Betriebliche AltersvorsorgeModern WorkplaceErgonomische Arbeitsplätze und moderne ITKostenfreie GetränkeRegelmäßige Team- und Firmenevents (z. B. Weihnachtsfeier, Grillen, Frühlingsfest, Herbstfest, Eisessen)Onboarding & PersonalentwicklungBei uns gehörst Du vom ersten Tag an ins Team, wirst eigenverantwortlich arbeiten und das in einem Team, das sich gegenseitig unterstütztDu erhältst eine umfangreiche EinarbeitungDurch regelmäßige Mitarbeitergespräche und individuelle Personalentwicklungsmaßnahmen wird Deine Entwicklung gefördertJährliche Mitarbeiterumfrage und WeiterbildungenWir bieten Dir eine E-Learning-Plattform, Sprachkurse und vieles mehr Standort Hu-Friedy Mfg. Co., LLC., Villingen-Schwenningen
Qualitätsingenieur Medizintechnik - Qualitätssysteme, CAPAs (m/w/d)
Hu-Friedy Mfg. Co., LLC., Konstanz
Über HuFriedyGroup:Die HuFriedyGroup ist mit insgesamt über 177 Jahren Erfahrung in der Dentalindustrie weltweit führend in den Bereichen Infektionsprävention, Instrumentenherstellung und Wiederaufbereitung von Instrumenten. Die HuFriedyGroup hilft Zahnärzten dabei, „Best in Practice“ zu sein, indem sie einen geschlossenen „Circle of Protection“ in der Praxis bereitstellt und erstklassige Produkte, Dienstleistungen, Weiterbildungen und Netzwerke bietet, die zu erstklassigen klinischen Leistungen und Ergebnissen führen und auch die Sicherheit für Behandler und Patienten gewährleistet.Als Teil der STERIS Gruppe, mit mehr als 18.000 Mitarbeitenden weltweit, bieten wir zusammen umfassende Produkte und Dienstleistungen für die Gesundheitsbranche. Unsere Aufgabe bei STERIS ist es, unseren Kunden dabei zu helfen, die Welt gesünder und sicherer zu machen.Werde Teil von STERIS! Für unser starkes Team am Standort Emmingen-Liptingen suchen wir eine analytische, kommunikationsstarke Persönlichkeit alsQualitätsingenieur (m/w/d) MedizintechnikDu verantwortest die Aufrechterhaltung, (Weiter-) Entwicklung und kontinuierliche Verbesserung (KVP) unserer Qualitätssysteme gemäß ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR etc. zur Steigerung unserer Produkt- und Servicequalität. Parallel dazu kümmerst Du Dich um die Qualifizierung von Produktionsanlagen und die Prozessvalidierung für drei Standorte (Deutschland, Griechenland, Italien) und arbeitest an Untersuchungen von Beschwerden / CAPAs und der Qualitätsoptimierung bei Lieferanten mit.Deine Aufgaben:Entwickeln und Umsetzen statistisch valider Stichproben- und Versuchspläne, Machbarkeitsstudien, SPC und TrendanalysenDurchführen von Audits des Qualitätssystems, Prüfen gesammelter Daten sowie Erheben statistischer Analysen rund um qualitätssteigernde Prozess- und ProduktanpassungenMonitoring und Bericht der Leistungskennzahlen sowie Initiieren von und / oder Teilnahme an Prozess- und ProduktkorrekturmaßnahmenErstellen, Dokumentieren und Aktualisieren von Arbeitsanweisungen inklusive Unterweisung der Teams in puncto Qualitätsgrundsätze, Korrekturmaßnahmen und gültige statistische TechnikenEnge interdisziplinäre Zusammenarbeit mit verschiedenen Bereichen bei qualitätsbezogenen FragenAufrechterhaltung der Produktintegrität und -qualität, z. B. durch die Bewertung und Disposition nicht konformer Materialien Dein Profil: Technisches oder betriebswirtschaftliches Studium, gern mit relevanten Weiterbildungen rund um QS und QMErfahrung im Projekt- und / oder Qualitätsmanagement, sicherer Umgang mit grundlegenden Qualitätstechniken und -planungen sowie Kenntnisse gültiger Normen, wie ISO 9001 und IATF 16949Gutes Deutsch und Englisch (Wort / Schrift) sowie routinierter Umgang mit MS Office20 % ReisebereitschaftWir bieten Dir:Sicherer Job im KundenserviceEinen unbefristeten und langfristigen Arbeitsplatz in einem globalen UnternehmenAttraktive Vergütung und GleitzeitJährlicher erfolgsbasierter Bonus30 Urlaubstage (plus Sonderurlaubstage)Betriebliche AltersvorsorgeModern WorkplaceErgonomische Arbeitsplätze und moderne ITKostenfreie GetränkeRegelmäßige Team- und Firmenevents (z. B. Weihnachtsfeier, Grillen, Frühlingsfest, Herbstfest, Eisessen)Onboarding & PersonalentwicklungBei uns gehörst Du vom ersten Tag an ins Team, wirst eigenverantwortlich arbeiten und das in einem Team, das sich gegenseitig unterstütztDu erhältst eine umfangreiche EinarbeitungDurch regelmäßige Mitarbeitergespräche und individuelle Personalentwicklungsmaßnahmen wird Deine Entwicklung gefördertJährliche Mitarbeiterumfrage und WeiterbildungenWir bieten Dir eine E-Learning-Plattform, Sprachkurse und vieles mehr Standort Hu-Friedy Mfg. Co., LLC., Konstanz
International Medical Science Liaison
Genomic Health, Inc., Düsseldorf
Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Company Overview Exact Sciences is dedicated to delivering patient critical answers across the cancer journey from early detection to treatment decision making. With a strong focus on people and an empathetic spirit, which fuels the company’s culture, driving them to create and deliver solutions rooted in the needs of patients, providers, and families. From earlier cancer detection to treatment guidance and monitoring, Exact Sciences are helping people get the answers they need to make more informed decisions across the cancer continuum. With a leading portfolio of products for earlier detection and treatment guidance, they help people face the most challenging decisions with confidence with a dedication to continuously innovate, combining scientific rigor with an open-minded approach to deliver the next big thing. Exact Sciences is continuously expanding the pipeline with the aim of tackling a wider array of cancer tests through the following measures: Expanding the Oncotype IQ platform to include liquid and tissue-based tests, all with the goal of making cancer care smarter. Adapting biomarker-based technologies create a liquid biopsy capable of detecting cancers and precancers from a blood sample. Using their proven multi-marker approach to achieve analytical sensitivity needed to discriminate between normal and cancerous samples. Collaborating with world-class clinicians and scientists at Mayo Clinic to identify biomarkers associated with the 15 deadliest cancers. Building a cancer detection platform upon learnings from the development of Cologuard (commercially available in the US only). By 2020, Oncotype DX will have been used to guide treatment decisions for more than 1 million cancer patients worldwide in breast, prostate and colon cancer. In July 2019 Exact Sciences acquired Genomic Health, a genetic cancer detection company based in Redwood City, California, for USD 2.8 billion, creating the leading global cancer diagnostics company. In 2020 Exact Sciences acquired Thrive Earlier Detection Corp., a Massachusetts-based healthcare company, in a multi-billion-dollar deal, and Base Genomics, which has technology for DNA methylation analysis. In February 2021 Exact Sciences announced the acquisition of Ashion Analytics, LLC (Ashion) from The Translational Genomics Research Institute (TGen), an affiliate of City of Hope. Ashion is a CLIA-certified and CAP-accredited sequencing lab based in Phoenix, Arizona with the genomics testing capabilities necessary to address the increasingly complex needs of clinical, academic, and biopharma customers focused on precision cancer treatments. The company is based in the United States, with International headquarters in Zug, Switzerland. Position Summary Representing the medical function, the MSL will act as a medical/clinical education liaison to external and internal stakeholders, while supporting commercial business and reimbursement objectives for the portfolio of products, most notably for breast and colorectal cancers. This role will engage with customers and colleagues across medical affairs and commercial groups to provide medical and scientific support for our on-market as well as help launch newer products into the international region. Near term business objectives include supporting growth of the Oncotype DX Breast Recurrence Score assay by providing medical information and education through scientific exchange in a fair-balanced manner to Medical Oncology, Surgeons, and Pathology Key Opinion Leaders as well as other healthcare professionals. In addition, the role supports the company’s R&D and investigator-initiated studies in the development and commercialization of genomic assays that lead to improved treatment decisions for oncology patients. To be an effective business partner MSLs develop and maintain outstanding knowledge of Exact Sciences products, competitor products, and other diagnostic options within therapeutic areas. MSLs must also maintain an in-depth understanding of the medical strategy and broader Exact Sciences strategy to ensure their own activities are coordinated and aligned. MSLs must be professionals with integrity and scientific creditability to interact with thought leaders, government health authorities, and medical centers of excellence. This position is based in Germany . Essential Duties Include, but are not limited to, the following: Inline Product & Team Support Deliver education of the broad healthcare provider (HCP) community, such as key opinion leaders (KOL’s), oncologists, pathologists, surgeons, nurses, and payors regarding Exact Sciences products as permissible by local laws and regulations.Serves as external, credible scientific expert on disease area and Exact Sciences products at HCP field meetings, key medical and scientific conferences, advisory boards, clinical investigator meetings and patient advocacy group meetings.Responds to unsolicited requests for medical information on Exact Sciences products in a credible, balanced/objective manner.Participate in the development and execution of a KOL outreach plans.Identify and map KOL, other stakeholder, key accounts as well as patient referral patterns and pathways.Maintain and develop synergistic relationships with KOLs to expand research, advisory, and educational partnership opportunities.Support medical-marketing initiatives, such as conference planning and support, medical education content development, faculty speaker training, sales training, reimbursement initiatives.Work with medical directors to take complex medical messages and position them to enable clear and concise understanding by both external audiences and partners within Exact Sciences.Stay abreast of new clinical developments, publications, and market trends to be a conduit for the greater medical team and other internal teams for review of these developments.Assist with set up and delivery of advisory boards, speaker trainings, and external payor reviews, as needed.Support preparation and presentation of medical review slides and materials at national sales meetings, pre-conference meetings, and field sales conference calls.Attend, develop summaries of, and present key medical findings from scientific congresses.Gather and interpret new clinical data from conferences and literature, as well as competitive intelligence, and report back on findings to medical affairs and marketing stakeholders. Pipeline & Clinical Trials Support Identify physicians currently managing patients with breast and colorectal cancer and cultivate a network of experts at academic and community centers to identify new trial sites and/or drive patient referrals and rapid enrolment.Delivers medical / scientific training to clinical study sites and provide input to key internal stakeholders on training materials for clinical trials, products in development, therapeutic areas, and disease state as outlined by the trial sponsor.Establishes and maintain strong working relationships with Principal Investigators (PIs) and clinical trial sites to support the enrollment and conduct of Exact Sciences clinical studies. Facilitate escalation of investigator questions/concerns, recruitment/retention initiatives and clinical site & investigators meetings as it relates to recruitment strategies. Minimum Qualifications Advanced degree in clinical specialty (PharmD, PhD, MD) with clinical experience. 3-5+ years’ experience as an MSL/CTL or senior clinical development role. 3+ years Oncology experience required. 3+ years of experience in pharmaceutical industry with knowledge of clinical research design and conduct. Preferred Qualifications Experience in Diagnostics or Biotech industry is a plus. Skills Excellent oral, written and presentation communication skills. Excellent English, multiple languages preferred. Proficient use of Microsoft Office Suite and other IT systems. Experience with VEEVA systems is a plus. Ability to independently deliver quality results in a timely manner. Ability to work as part of a team. Cultural Impact Highest integrity and ethical behavior. Mutual respect for colleagues. Collaborative within teams, uses resources carefully and can build a great place to work and grow. Ability to interact within culturally diverse teams. Business acumen and innovative mindset. Ability to manage though complexity and ambiguity, while focusing on the end goal. Discretion with sensitive and confidential information. Other Ability to travel 60-70% % of working time away from work location, may include overnight/weekend travel. #LI-TK1 Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. Standort Genomic Health, Inc., Düsseldorf
International Medical Science Liaison
Genomic Health, Inc., Berlin
Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Company Overview Exact Sciences is dedicated to delivering patient critical answers across the cancer journey from early detection to treatment decision making. With a strong focus on people and an empathetic spirit, which fuels the company’s culture, driving them to create and deliver solutions rooted in the needs of patients, providers, and families. From earlier cancer detection to treatment guidance and monitoring, Exact Sciences are helping people get the answers they need to make more informed decisions across the cancer continuum. With a leading portfolio of products for earlier detection and treatment guidance, they help people face the most challenging decisions with confidence with a dedication to continuously innovate, combining scientific rigor with an open-minded approach to deliver the next big thing. Exact Sciences is continuously expanding the pipeline with the aim of tackling a wider array of cancer tests through the following measures: Expanding the Oncotype IQ platform to include liquid and tissue-based tests, all with the goal of making cancer care smarter. Adapting biomarker-based technologies create a liquid biopsy capable of detecting cancers and precancers from a blood sample. Using their proven multi-marker approach to achieve analytical sensitivity needed to discriminate between normal and cancerous samples. Collaborating with world-class clinicians and scientists at Mayo Clinic to identify biomarkers associated with the 15 deadliest cancers. Building a cancer detection platform upon learnings from the development of Cologuard (commercially available in the US only). By 2020, Oncotype DX will have been used to guide treatment decisions for more than 1 million cancer patients worldwide in breast, prostate and colon cancer. In July 2019 Exact Sciences acquired Genomic Health, a genetic cancer detection company based in Redwood City, California, for USD 2.8 billion, creating the leading global cancer diagnostics company. In 2020 Exact Sciences acquired Thrive Earlier Detection Corp., a Massachusetts-based healthcare company, in a multi-billion-dollar deal, and Base Genomics, which has technology for DNA methylation analysis. In February 2021 Exact Sciences announced the acquisition of Ashion Analytics, LLC (Ashion) from The Translational Genomics Research Institute (TGen), an affiliate of City of Hope. Ashion is a CLIA-certified and CAP-accredited sequencing lab based in Phoenix, Arizona with the genomics testing capabilities necessary to address the increasingly complex needs of clinical, academic, and biopharma customers focused on precision cancer treatments. The company is based in the United States, with International headquarters in Zug, Switzerland. Position Summary Representing the medical function, the MSL will act as a medical/clinical education liaison to external and internal stakeholders, while supporting commercial business and reimbursement objectives for the portfolio of products, most notably for breast and colorectal cancers. This role will engage with customers and colleagues across medical affairs and commercial groups to provide medical and scientific support for our on-market as well as help launch newer products into the international region. Near term business objectives include supporting growth of the Oncotype DX Breast Recurrence Score assay by providing medical information and education through scientific exchange in a fair-balanced manner to Medical Oncology, Surgeons, and Pathology Key Opinion Leaders as well as other healthcare professionals. In addition, the role supports the company’s R&D and investigator-initiated studies in the development and commercialization of genomic assays that lead to improved treatment decisions for oncology patients. To be an effective business partner MSLs develop and maintain outstanding knowledge of Exact Sciences products, competitor products, and other diagnostic options within therapeutic areas. MSLs must also maintain an in-depth understanding of the medical strategy and broader Exact Sciences strategy to ensure their own activities are coordinated and aligned. MSLs must be professionals with integrity and scientific creditability to interact with thought leaders, government health authorities, and medical centers of excellence. This position is based in Germany . Essential Duties Include, but are not limited to, the following: Inline Product & Team Support Deliver education of the broad healthcare provider (HCP) community, such as key opinion leaders (KOL’s), oncologists, pathologists, surgeons, nurses, and payors regarding Exact Sciences products as permissible by local laws and regulations.Serves as external, credible scientific expert on disease area and Exact Sciences products at HCP field meetings, key medical and scientific conferences, advisory boards, clinical investigator meetings and patient advocacy group meetings.Responds to unsolicited requests for medical information on Exact Sciences products in a credible, balanced/objective manner.Participate in the development and execution of a KOL outreach plans.Identify and map KOL, other stakeholder, key accounts as well as patient referral patterns and pathways.Maintain and develop synergistic relationships with KOLs to expand research, advisory, and educational partnership opportunities.Support medical-marketing initiatives, such as conference planning and support, medical education content development, faculty speaker training, sales training, reimbursement initiatives.Work with medical directors to take complex medical messages and position them to enable clear and concise understanding by both external audiences and partners within Exact Sciences.Stay abreast of new clinical developments, publications, and market trends to be a conduit for the greater medical team and other internal teams for review of these developments.Assist with set up and delivery of advisory boards, speaker trainings, and external payor reviews, as needed.Support preparation and presentation of medical review slides and materials at national sales meetings, pre-conference meetings, and field sales conference calls.Attend, develop summaries of, and present key medical findings from scientific congresses.Gather and interpret new clinical data from conferences and literature, as well as competitive intelligence, and report back on findings to medical affairs and marketing stakeholders. Pipeline & Clinical Trials Support Identify physicians currently managing patients with breast and colorectal cancer and cultivate a network of experts at academic and community centers to identify new trial sites and/or drive patient referrals and rapid enrolment.Delivers medical / scientific training to clinical study sites and provide input to key internal stakeholders on training materials for clinical trials, products in development, therapeutic areas, and disease state as outlined by the trial sponsor.Establishes and maintain strong working relationships with Principal Investigators (PIs) and clinical trial sites to support the enrollment and conduct of Exact Sciences clinical studies. Facilitate escalation of investigator questions/concerns, recruitment/retention initiatives and clinical site & investigators meetings as it relates to recruitment strategies. Minimum Qualifications Advanced degree in clinical specialty (PharmD, PhD, MD) with clinical experience. 3-5+ years’ experience as an MSL/CTL or senior clinical development role. 3+ years Oncology experience required. 3+ years of experience in pharmaceutical industry with knowledge of clinical research design and conduct. Preferred Qualifications Experience in Diagnostics or Biotech industry is a plus. Skills Excellent oral, written and presentation communication skills. Excellent English, multiple languages preferred. Proficient use of Microsoft Office Suite and other IT systems. Experience with VEEVA systems is a plus. Ability to independently deliver quality results in a timely manner. Ability to work as part of a team. Cultural Impact Highest integrity and ethical behavior. Mutual respect for colleagues. Collaborative within teams, uses resources carefully and can build a great place to work and grow. Ability to interact within culturally diverse teams. Business acumen and innovative mindset. Ability to manage though complexity and ambiguity, while focusing on the end goal. Discretion with sensitive and confidential information. Other Ability to travel 60-70% % of working time away from work location, may include overnight/weekend travel. #LI-TK1 Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. Standort Genomic Health, Inc., Berlin