TMF Lead I
Core
Lead clinical trial master file (TMF) management, ensuring inspection-ready documentation and compliance with GCP and regulatory guidelines for complex studies.
Role type
Senior TMF Lead (Subject Matter Expert)
Builds
Inspection-ready TMFs and compliance frameworks for clinical studies
Domain
Clinical Research / Regulatory Compliance
Required skills
TMF management, GCP/ICH regulations, audit/inspection support, risk mitigation, project coordination, quality review oversight, close-out management, mentorship
Preferred skills
None stated
Technologies
eTMF systems
Responsibilities
Create and execute study TMF Plans and Document Indexes; ensure timely document review, processing, and archival; monitor TMF health metrics and identify 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
