# eTMF-Functional & Systems Specialist

> Excelya · Boston, United States (Hybrid) · Full-time · Posted 2026-09-24

**Workplace:** hybrid

**Department:** eTMF - Resourcing

## 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.

**Key Responsibilities:**

-   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.

## Requirements

-   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.

## 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.

## Apply

[Apply at Excelya](https://apply.workable.com/excelya/j/ABA467E09E/apply)

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