Senior Clinical Trial Associate

The Trial Master File Associate provides autonomous sponsor-side oversight of TMF activities across assigned clinical studies and supports compliant management of the R&D archive. The role works with CROs, study teams, Quality and Information Technology to maintain TMF quality, inspection readiness, reliable transfer and archiving, and clear traceability of risks, decisions and actions.

CORE 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 concise status updates on risks, overdue actions and decisions.

REQUIRED EDUCATION AND EXPERIENCE

• University degree in Life Sciences, Information Management, Library or Archival Science, or a relevant discipline.

• Minimum 3-4 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.

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.