eTMF Specialist

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., * 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

Do you have a Master’s degree?, *

• 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)

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.