Sr Clinical Project Manager
Core
Lead planning and execution of complex IVD clinical studies, ensuring results are completed on time and within budget for regulated, high-volume testing environments.
Role type
Senior Clinical Project Manager (IVD)
Builds
Clinical study protocols, safety plans, study reports, and trial master files for regulatory submission.
Domain
Life Sciences / In Vitro Diagnostics (IVD) / Clinical Research
Required skills
Clinical study planning, protocol development, regulatory compliance (FDA/GCP/ISO), vendor management, budget tracking, cross-functional team leadership, clinical monitoring, risk management, documentation management.
Preferred skills
Experience with investigational sites, KOL engagement, clinical trial registration.
Responsibilities
Develop clinical study protocols, informed consent forms, and case report forms; oversee external vendors to ensure on-time, on-budget delivery; ensure compliance with FDA regulations, ISO standards, and GCP; monitor study participant safety; manage clinical study budgets and accruals; conduct on-site clinical monitoring; prepare clinical study reports for regulatory authorities; maintain trial master files; interact with investigational sites, vendors, and key opinion leaders.
Seniority
Senior, hands-on IC