Clinical Affairs Manager
Core
Planning, executing, and reporting company-sponsored clinical studies to support IVD product submissions, label claims, and post-market obligations.
Role type
Senior individual contributor Clinical Affairs Manager
Builds
Clinical Affairs infrastructure (SOPs, TMF structures, vendor oversight frameworks) and operationalizes clinical study execution for IVD products.
Domain
Medical Device / In Vitro Diagnostics (IVD) / Clinical Research
Required skills
Clinical study execution under GCP, Regulatory submission authoring (FDA/CE), CRO/vendor oversight, SOP development, Clinical data management, Project management, Scientific writing
Preferred skills
IVD/NGS assay clinical validation, Building Clinical Affairs function from scratch, Medical Affairs/KOL interface, Clinical research certification (ACRP/SOCRA), Post-market performance follow-up
Technologies
Electronic data capture systems, Clinical study management tools
Responsibilities
Develop and implement Clinical Affairs SOPs and processes for study feasibility, protocol development, and study closeout; Serve as sponsor-side operational lead for active clinical studies including protocol authorship and monitoring oversight; Author and coordinate clinical sections of regulatory submissions (510(k), De Novo, PMA, IVDR); Partner with Biostatistics and Data Management to ensure clinical data are analyzable and submission-ready; Mentor future Clinical Affairs hires as the function scales.
Seniority
Senior, hands-on IC
