About this role
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.
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. 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.
As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.
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 concise status updates on risks, overdue actions and decisions.
Qualifications
• 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.
• Working knowledge of Veeva Vault eTMF or eTMF Archive and of ICH-GCP, GxP and ALCOA+ principles.
• Ability to work independently, manage competing priorities and deliver clear, traceable outputs.
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.