Clinical Trials Manager
Core
Managing geographical regions or components of Post-Authorization Non-Interventional Studies (NIS) to fulfill regulatory commitments, safety obligations, and evidence needs for regulatory filings.
Role type
Clinical Trials Manager (Post-Authorization Non-Interventional Studies)
Builds
Regulatory evidence packages for product registration and commercialization
Domain
Biopharmaceuticals / Clinical Operations
Deliverable
client delivery
Required skills
Study logistics planning, cross-functional collaboration, CRO/vendor oversight, site evaluation and close-out management, timeline and documentation management
Preferred skills
Strategic project participation
Technologies
Clinical trial management systems (implied by study plans/logistics)
Responsibilities
Manage geographical regions of assigned clinical studies or multiple components of larger studies; Define and develop clinical study plans; Oversee site evaluation, initiation, and close-out visits; Manage study timelines, documentation, and communications
Seniority
Mid-level operational manager
