Senior TMF Associate

About the role

TFS HealthScience is a global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. The Senior TMF Associate provides autonomous sponsor-side oversight of TMF activities across assigned clinical studies and supports compliant management of the R&D archive. Working with CROs, study teams, Quality and Information Technology, the role maintains TMF quality, inspection readiness, reliable transfer and archiving, and clear traceability of risks, decisions and actions. The role sits within the SRS/FSP team and is dedicated to one sponsor, a global pharmaceutical or biotechnology company.

Key responsibilities

• Provide sponsor-side TMF oversight from study set-up through close-out, transfer and archiving.
• Review TMF Plans, TMF Indexes, Expected Document Lists and CRO oversight arrangements.
• Monitor TMF completeness, quality and timeliness, identify gaps and coordinate corrective follow-up.
• Guide study teams and CROs on TMF responsibilities, document expectations and inspection readiness.
• Coordinate TMF transfers, mapping, reconciliation and risk-based post-transfer verification.
• Support Veeva Vault eTMF Archive activities, including study set-up, access, UAT and operational support.
• Maintain portfolio tracking of TMF locations, transfers, archived records, findings and ownership.
• Draft and improve TMF SOPs, Work Instructions, templates, checklists, guidance and training materials.
• Maintain the R&D archive and coordinate custody, retrieval, shipments, records controls and archive vendors.
• Support audits and inspections and provide status updates on risks, overdue actions and decisions.

Required profile

• University degree in Life Sciences, Information Management, Library or Archival Science, or a relevant discipline.
• Fluent professional English.
• Minimum 6+ years of relevant TMF, clinical documentation or clinical operations experience, including substantial direct TMF responsibility.
• Demonstrated autonomous sponsor-side or equivalent oversight across multiple studies and CRO delivery models.
• Experience with TMF quality metrics, issue management, transfers, reconciliation, verification and archiving.
• Ability to work independently, manage competing priorities and deliver clear, traceable outputs.

Required skills

• Working knowledge of Veeva Vault eTMF or eTMF Archive.
• Knowledge of ICH-GCP, GxP and ALCOA+ principles.