eTMF coordinator

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

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

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

Key responsibilities :

• Manage theend‑to‑end lifecycle of eTMFs, including setup, maintenance, and close‑out for clinical studies
• Performregular quality control checks to ensure document completeness, accuracy, and compliance with regulatory standards
• Monitor and trackTMF metrics and KPIs to ensure inspection readiness
• Review and approveTMF management plans for internal teams and CROs
• Act as aSubject Matter Expert (SME), providing guidance and training on eTMF best practices
• Develop, update, and maintainSOPs, templates, and processes related to TMF management
• Serve as themain point of contact for eTMF-related queries, audits, and inspections
• Ensure compliance of the eTMF system withvalidation and regulatory requirements
• Manageuser access, system updates, and migrations, and assess the impact of new system releases
• Collaborate with IT teams toresolve system issues and support continuous improvement

• Education: Bachelor’s or Master’s degree inHealth Sciences, Life Sciences, or related field
• Experience: Strong experience in clinical trial documentation management
• Technical Skills:

-Hands‑on experience withVeeva Vault TMF (mandatory)

-Strong understanding of theDIA TMF Reference Model

-Experience withTMF metrics, KPIs, and dashboards

• Knowledge:

-Strong knowledge ofICH/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)

Why 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.