TMF Lead I
Core
Lead the maintenance, quality review, and archival of Trial Master Files (TMF) for clinical studies to ensure compliance with GCP and regulatory standards.
Role type
Senior TMF Lead (Clinical Operations)
Builds
Inspection-ready TMFs for clinical trials
Domain
Clinical Research / Regulatory Compliance
Required skills
GCP regulations knowledge, TMF management, risk identification, audit support, mentorship, project coordination
Preferred skills
None stated
Technologies
eTMF systems
Responsibilities
Ensure timely and high-quality TMF document review, processing, and archival; Create and execute TMF Plans and Document Indices; Monitor TMF health metrics and escalate risks; Serve as SME for audits and inspections; Mentor less experienced TMF Leads; Manage study close-out activities.
Seniority
Senior, hands-on IC with mentorship responsibilities
