Manager - TMF Operations
Core
Oversee the management, maintenance, and compliance of the Trial Master File (TMF) for clinical research studies to ensure audit readiness and regulatory adherence.
Role type
Manager, TMF Operations
Builds
Trial Master Files (TMF) for clinical studies
Domain
Clinical research / Healthcare
Required skills
TMF management, GCP compliance, regulatory requirements, team leadership, project management, electronic TMF systems, process improvement
Preferred skills
None stated
Technologies
Electronic TMF systems, document management tools
Responsibilities
Manage TMF Operations team, oversee document collection and filing, collaborate with cross-functional teams, develop TMF management strategies, monitor quality metrics, provide leadership and training, ensure audit readiness
Seniority
Manager, team leadership
