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TMF (Trial Master File) Specialist

SK Life Science Inc. • Paramus, NJ, US • published 2026-10-07 15:03:33.309764

Description

Overview: 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 str...

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