Sr. TMF Specialist - Contract

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. TMF Specialist - Contract based in United States.

• This is a senior-level Clinical Operations opportunity focused on maintaining the operational integrity, quality, and organization of the Trial Master File (TMF).
• You will manage critical TMF activities including document uploads, quality control, access management, completeness checks, reconciliations, transfers, and archival.
• The role plays an important part in ensuring trial documentation remains accurate, complete, inspection-ready, and aligned with applicable TMF expectations.
• You will work closely with functional content owners, CROs, vendors, and cross-functional teams to resolve quality issues and maintain consistent documentation standards.
• The position also provides exposure to audits, inspection readiness, CRO-owned TMFs, and periodic functional quality reviews.
• This is a fully remote contract role for approximately six months, offering an opportunity to contribute independently within a clinical development environment.
• The ideal candidate is organized, detail-oriented, knowledgeable in TMF practices and regulations, and comfortable taking ownership of time-sensitive documentation activities.