Clinical Affairs Manager, In Vitro Diagnostics
1 week ago
We are seeking a highly skilled Clinical Affairs Manager to join our Regulatory and Clinical Affairs organization. This role will be responsible for ensuring compliance with Good Clinical Practice, regulatory requirements, and FDA submissions for our in vitro diagnostics products.
Key Responsibilities- Participate in clinical study planning, core team support, and CRO management
- Work closely with regulatory representatives, core teams, and CROs to ensure compliance with regulatory requirements
- Document clinical studies plans and reports for inclusion in the Design History File (DHF) project
- Interact with pharmaceutical partners to ensure IVD study requirements are met
- Facilitate internal and external clinical studies preparation and planning meetings
- Ensure CRO activities and timelines align with regulatory and project requirements
- Bachelor's degree in biology, chemistry, bio-engineering, or related science
- Solid understanding of Good Clinical Practices
- 4+ years of experience in the In Vitro Diagnostic or Medical Device Industry, with companion diagnostic experience a plus
- 4+ years of demonstrated experience managing in-house and/or external clinical studies
- Certification as a Clinical Research Professional (CCRP) is a plus
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
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