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 stakeholders (Clinical, QA, PV, Biometry, etc.)

Languages: Fluent English (written and spoken)

Benefits

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.