Clinical Trial Manager In Vitro DiagnosticsMedical Devices
Clinical Trial Manager In Vitro DiagnosticsMedical Devices
Posted on :
03-02-2025
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1 Vacancy
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Job Description
Job Title: Clinical Trial Manager In Vitro Diagnostics/Medical Devices
Job Location: Great Britain United Kingdom
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Kelly FSP on behalf of reputed client is recruiting for UKbased Clinical Trial Manager with considerable Medical Devices experience.
Career Responsibilities:
- Study Management and Monitoring:
- Design plan and execute study management and clinical monitoring activities of largescale trials in support of IVDR submissions for diagnostic devices.
- Prepare and author IVDR gap assessments and Clinical Performance Reports.
- Operational Support:
- Provide comprehensive support for all operational aspects of clinical trials including the review and approval of protocols and studyrelated documents (e.g. Regulatory Binder Work Instructions CRF Completion Guidelines).
- Team Leadership and Delegation:
- Effectively lead the operational clinical team for assigned studies delegating appropriate tasks assignments and responsibilities to subordinates.
- Budget and Schedule Management:
- Develop and administer budgets schedules and performance requirements for assigned studies.
- Oversee the successful and efficient execution of assigned studies from startup to closeout.
- Vendor and CRO Management:
- Participate in CRO/vendor selection processes for outsourced activities as applicable.
- Manage interactions with Clinical Research Organizations (CROs) including sponsor oversight of relevant functional activities (e.g. study management monitoring site management project master files and data management).
- Contract and Protocol Development:
- Collaborate with the Legal Department to develop study contract templates across the trial and for each study site.
- Provide feedback on study/protocol design as needed.
- Site Monitoring and Compliance:
- Develop Site Monitoring Plans and ensure CRA compliance with the plan.
- Review monitoring visit reports and ensure adherence to study timelines for report submission and finalization.
- Site StartUp Activities:
- Participate in site startup activities including site selection and regulatory document collection review approval and tracking.
- Develop informed consent forms/assent forms as applicable.
- General Responsibilities:
- Work under minimal supervision and demonstrate a high degree of proficiency.
- Handle additional projects and tasks as determined by department and organizational needs.
- Travel approximately 2050%.
Education & Experience:
- Minimum BA or BS degree and 10 years of related experience.
- Master’s degree or Medical Technology Certification preferred.
- Familiarity with IVDR.
- Experience in managing external CROs and onsite monitoring of IVD clinical studies is preferred.
Technical Skills/Knowledge/Abilities:
- Strong technical writing skills.
- Deep understanding of IVDR and its applications.
- Advanced knowledge of clinical trial practices and regulations.
- Advanced knowledge of clinical trial design databases and data analysis for IVD clinical trials.
Join us!
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Employment Type
Full Time
Key Skills
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