TMF (Trial Master File) Specialist

About the role

The TMF Specialist is a member of Clinical Operations and serves as the sponsor’s Trial Master File subject matter expert. This role provides proactive, end-to-end TMF ownership and oversight across clinical studies, from study start-up and TMF establishment through study conduct, closeout, final reconciliation, transfer, and archival. The position is responsible and accountable for ensuring that sponsor- and CRO-managed TMFs are complete, accurate, timely, inspection ready, and maintained in accordance with applicable regulations, ICH GCP, internal SOPs, study-specific TMF plans, and company quality standards. The role identifies gaps, establishes corrective actions, follows issues through documented resolution, and escalates significant or persistent deficiencies when necessary.

Responsibilities

• Serve as the primary Clinical Operations TMF subject matter expert and central point of contact for TMF activities across all assigned clinical studies.
• Provide end-to-end ownership and sponsor oversight of the TMF lifecycle, from study start-up through study conduct, closeout, finalization, and archival.
• Establish and review study-specific TMF plans, filing structures, document expectations, ownership, timelines, quality requirements, and escalation pathways at study initiation.
• Oversee CRO and vendor TMF activities for compliance with contractual requirements