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 global registration.
Role type
Clinical Trial Manager (Post-Authorization Non-Interventional Studies)
Builds
Regulatory evidence packages for product registration and commercialization
Domain
Life Sciences / Clinical Operations / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Study logistics planning, CRO/vendor oversight, site evaluation and close-out management, regulatory document review, safety report preparation, cross-functional collaboration, SOP development
Preferred skills
Experience with Medical Affairs and Real World Evidence teams, tool/process optimization, training new colleagues
Technologies
Clinical study management tools, regulatory databases
Responsibilities
Define and incorporate study logistics and plans, oversee CRO monitoring visits, manage study timelines and documentation, provide input into protocols and case report forms, lead preparation of safety and final study reports, identify operational challenges and propose solutions, contribute to SOP development
Seniority
Mid-level, hands-on IC
