eTMF Specialist

Join Excelya , a dynamic and innovative company committed to excellence and collaboration in the field of translational research.

The eTMF Specialist plays a key role within the Clinical Development Platform by ensuring the quality, compliance, and inspection readiness of the electronic Trial Master File (eTMF) across global clinical trials.

This role requires strong expertise in clinical documentation management , close collaboration with cross‑functional teams, and active involvement in audits and inspections within a regulated environment.

Key responsibilities : Manage the end‑to‑end lifecycle of eTMFs, including setup, maintenance, and close‑out for clinical studies Perform regular quality control checks to ensure document completeness, accuracy, and compliance with regulatory standards Monitor and track TMF metrics and KPIs to ensure inspection readiness Review and approve TMF management plans for internal teams and CROs Act as a Subject Matter Expert (SME) , providing guidance and training on eTMF best practices Develop, update, and maintain SOPs, templates, and processes related to TMF management Serve as the main point of contact for eTMF-related queries, audits, and inspections Ensure compliance of the eTMF system with validation and regulatory requirements Manage user access, system updates, and migrations , and assess the impact of new system releases Collaborate with IT teams to resolve system issues and support continuous improvement Requirements Education: Bachelor’s or Master’s degree in Health Sciences, Life Sciences, or related field Experience: Strong experience in clinical trial documentation management Technical Skills: -Hands‑on experience with Veeva Vault TMF (mandatory) -Strong understanding of the DIA TMF Reference Model -Experience with TMF metrics, KPIs, and dashboards Knowledge: -Strong knowledge of ICH/GCP guidelines and regulatory requirements -Understanding of clinical trial documentation lifecycle -Knowledge of cross‑functional stakeho