eTMF Specialist

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

The successful candidate will work closely with Clinical Project Managers, Clinical Trial Associates, Clinical Operations teams, and CRO partners to ensure TMFs remain complete, compliant, and inspection-ready throughout the study lifecycle.

Key Responsibilities:

• Manage and maintain TMF/eTMF documentation throughout the entire clinical trial lifecycle, from start-up to archiving.
• Ensure TMF completeness, quality, accuracy, and inspection readiness at all times.
• Conduct TMF quality reviews, reconciliation activities, and completeness assessments.
• Track, follow up, and resolve missing, incomplete, or overdue study documents.
• Monitor and report TMF health, quality, and compliance metrics.
• Collaborate closely with Clinical Project Managers, Clinical Operations teams, CTAs, and CRO partners.
• Provide guidance on TMF requirements, filing standards, documentation practices, and compliance expectations.
• Manage daily activities within Veeva Vault eTMF, including document filing, classification, and metadata management.
• Serve as a Subject Matter Expert (SME) for eTMF processes and Veeva Vault, while supporting process improvements and system enhancements.
• Ensure compliance with ICH-GCP, regulatory requirements, and SOPs, support audits and inspections, contribute to remediation plans, and deliver TMF-related training and best practices to study teams and CROs.

Requirements

• Bachelor’s degree in Life Sciences or a related scientific discipline.

• Minimum 5 years of experience in TMF/eTMF management within clinical research.
• Proven hands-on expertise with Veeva Vault eTMF.
• Strong understanding of Clinical Operations and end-to-end clinical trial processes.
• Experience supporting inspection readiness, audits, and regulatory inspections.
• Solid knowledge of ICH-GCP guidelines and the TMF Reference Model.
• Experience collaborating with CROs and cross-functional clinical study teams.
• Strong communication, stakeholder management, and organizational skills.

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.