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.

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.