Participate as a Clinical Affairs representative to project core teams.
Work closely with core team and Regulatory Representative during the study planning, coordination, execution, and management phases.
Develop clinical study plans/reports for inclusion into the project Design History File (DHF).
Lead all aspects of clinical study execution on assigned projects, including site qualifications, selections, visits, study monitoring, and eTMF completion.
Facilitate internal and external clinical studies preparation and planning meetings.
Interact as the primary interface between the company, CRO, and study sites.
Ensure that CRO activities and timelines are in coordination with regulatory and project requirements.
Coordinate and connect with cross-functional team on projects to ensure project progress.
Promptly advise the Clinical Affairs Director and project core teams of any clinical study issues as they arise.
Update Clinical Affairs procedures to ensure alignment with global regulations and guidelines.
Manage and lead clinical projects and initiatives.
Cross functional training on clinical affairs activities and processes.
Qualifications
Bachelor's degree in Biology, Chemistry, bio-engineering or related science, or equivalent experience
Confirmed understanding of Good Clinical Practices and international clinical study regulation is required (e.g. IVDR)
Clinical Research Professional Certificate (CCRP) or equivalent is a plus
If certification is not in place, class work/course work in Good Clinical Practices is required
Minimum of 5 years working in the In Vitro Diagnostic (IVDs) or Medical Device Industry
Minimum of 5 years proven experience managing in-house and/or external clinical studies
Experience working with multi-functional project teams is required.
Digital literacy is required: proficiency with Microsoft Office suite, eDC, eTMF tools.
