Job title:
Clinical Trial Manager – In Vitro Diagnostics/Medical Devices
Company
Lifelancer
Job description
Job Title: Clinical Trial Manager – In Vitro Diagnostics/Medical DevicesJob Location: Great Britain, United KingdomJob Location Type: RemoteJob Contract Type: Full-timeJob Seniority Level: Mid-Senior levelKelly FSP, on behalf of reputed client, is recruiting for UK-based 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 large-scale 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 study-related 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 start-up to close-out.
- 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 Start-Up Activities:
- Participate in site start-up 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 20-50%.
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 on-site 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!Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.For more details and to find similar roles, please check out the below Lifelancer link.
Expected salary
Location
London
Job date
Tue, 04 Feb 2025 23:27:11 GMT
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