Clinical Affairs Manager
Core
Senior individual contributor responsible for planning, executing, and reporting company-sponsored clinical studies to support IVD product submissions and label claims.
Role type
Senior IC Clinical Affairs Manager
Builds
Clinical Affairs infrastructure including SOPs, trial master file structures, and CRO/vendor oversight frameworks.
Domain
Medical device / In Vitro Diagnostics (IVD) / Clinical Research
Required skills
Clinical study execution under GCP, Regulatory submission authoring (FDA/CE), SOP development, CRO/vendor management, Cross-functional liaison, Project management
Preferred skills
IVD/NGS assay validation, Function building from scratch, Medical Affairs interface, Clinical certifications (ACRP/SOCRA)
Technologies
Electronic data capture systems, Clinical study reporting tools
Responsibilities
Develop and implement Clinical Affairs SOPs and processes for study feasibility, protocol development, and monitoring; Serve as sponsor-side operational lead for active clinical studies including protocol authorship and site management; Author and coordinate clinical sections of regulatory submissions (510(k), De Novo, PMA, IVDR); Partner with Medical Affairs on study design, intended claims, and publication strategy; Mentor future Clinical Affairs hires as the function scales.
Seniority
Senior, hands-on IC
