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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # eTMF-Functional & Systems Specialist - **Company:** Excelta Corporation - **Location:** Boston, MA, United States - **Contract:** Permanent contract - **Skills:** Clinical Trial Management Systems, Requirements Management, Software Requirements Analysis, System Testing, Computerised Systems, VeevaVault, GXP - **Published:** September 27, 2026 - **Apply:** https://www.careerbuilder.com/job-details/etmf-functional-systems-specialist-boston-ma--dc56a931-cf45-43c4-bf68-0d57ce340e0a ## About the Role * 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 ## Description 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. ## Related Videos - [Microservices architecture as a key element in building trading systems for global finance markets](https://www.wearedevelopers.com/videos/1196-microservices-architecture-as-a-key-element-in-building-trading-systems-for-global-finance-markets) - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [How To Test A Ball of Mud](https://www.wearedevelopers.com/videos/173-how-to-test-a-ball-of-mud) - [Testing .NET applications a Tool box for every developer](https://www.wearedevelopers.com/videos/704-testing-net-applications-a-tool-box-for-every-developer) - [Building the Right Product and Building It Right: A Glimpse into Extreme Programming, Atomic Design ](https://www.wearedevelopers.com/videos/398-building-the-right-product-and-building-it-right-a-glimpse-into-extreme-programming-atomic-design) - [How I Built QA from Scratch in a Scaling Startup - no fluff real life story](https://www.wearedevelopers.com/videos/2041-how-i-built-qa-from-scratch-in-a-scaling-startup-no-fluff-real-life-story) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Integration And E2E Testing: Are They Complementary or Interchangeable?](https://www.wearedevelopers.com/magazine/86-integration-and-e2e-testing-are-they-complementary-or-interchangeable) - [Best Companies to work for in London: Top 25 Companies in 2023](https://www.wearedevelopers.com/magazine/187-best-companies-to-work-for-in-london-top-25-companies-in-2023) - [The 8 Best Code Testing Tools](https://www.wearedevelopers.com/magazine/402-the-8-best-code-testing-tools) - [How Many Jobs Are Available in Technology?](https://www.wearedevelopers.com/magazine/450-how-many-jobs-are-available-in-technology) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs)