eTMF-Functional & Systems 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.

In this role, you will join an existing eTMF team and work closely with the new eTMF Director based in the United States, as well as with Clinical Operations stakeholders and Clinical Project Managers.

This is not a pure IT/developer position. The consultant should be able to understand business needs and translate them into system requirements and changes, while supporting the associated testing and validation activities., * Support the administration, maintenance, and continuous improvement of the Veeva Vault eTMF platform.

• Serve as a functional point of contact for eTMF and Clinical Operations stakeholders.
• Gather, analyze, and translate business requirements into functional specifications and user stories.
• Support system enhancements, releases, and the implementation of new functionalities.
• Prepare and execute testing activities, including User Acceptance Testing (UAT), and manage issue resolution.
• Contribute to Computerized System Validation (CSV), change control, and GxP compliance activities.
• Provide user support and training while collaborating closely with Clinical Operations, Quality, IT, and global teams.

• Hands-on experience with Veeva Vault eTMF and a strong understanding of eTMF processes.
• Solid knowledge of Clinical Operations within a clinical research environment.
• Experience working with computerized systems in GxP-regulated settings.
• Good understanding of Computerized System Validation (CSV) principles and activities.
• Experience managing system changes, change controls, and system lifecycle activities.
• Ability to gather business requirements and translate them into functional specifications and User Stories.
• Experience preparing, executing, and coordinating testing activities, including UAT.
• Strong communication and stakeholder management skills, with experience working in global cross-functional teams
• Fluent in English., Acceptance Testing, Administrative Skills, Business Analysis, Business Skills, Change Control, Change Management, Clinical Research, Clinical Trial Management, Communication Skills, Consulting, Continuous Improvement, Contract Research Organization (CRO), Cross-Functional, Customer Support/Service, English Language, GxP, Healthcare Quality, Needs Assessment, Operational Improvement, Problem Solving Skills, Requirements Management, Standards of Care, System Lifecycle, System Validation, Systems Administration/Management, Team Player, Validation Testing

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.