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 studiesPerform regular quality control checks to ensure document completeness, accuracy, and compliance with regulatory standardsMonitor and track TMF metrics and KPIs to ensure inspection readinessReview and approve TMF management plans for internal teams and CROsAct as a Subject Matter Expert (SME), providing guidance and training on eTMF best practicesDevelop, update, and maintain SOPs, templates, and processes related to TMF managementServe as the main point of contact for eTMF-related queries, audits, and inspectionsEnsure compliance of the eTMF system with validation and regulatory requirementsManage user access, system updates, and migrations, and assess the impact of new system releasesCollaborate with IT teams to resolve system issues and support continuous improvementRequirementsEducation: Bachelor’s or Master’s degree in Health Sciences, Life Sciences, or related fieldExperience: Strong experience in clinical trial documentation managementTechnical Skills:-Hands‑on experience with Veeva Vault TMF (mandatory)-Strong understanding of the DIA TMF Reference Model-Experience with TMF metrics, KPIs, and dashboardsKnowledge:-Strong knowledge of ICH/GCP guidelines and regulatory requirements-Understanding of clinical trial documentation lifecycle-Knowledge of cross‑functional stakeholders (Clinical, QA, PV, Biometry, etc.)Languages:Fluent English (written and spoken)BenefitsWhy Join Us?At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.Here’s what makes us unique—We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.Originally posted on Himalayas