# eTMF Specialist

> Excelya · Paris, France (Remote) · — · Posted 2026-06-25

**Workplace:** remote

**Department:** eTMF - Resourcing

## Description

Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.

The **eTMF Specialist** plays a key role within the Clinical Development Platform by ensuring the **quality, compliance, and inspection readiness** of the electronic Trial Master File (eTMF) across global clinical trials.

This role requires strong expertise in **clinical documentation management**, close collaboration with cross‑functional teams, and active involvement in audits and inspections within a regulated environment.

**Key responsibilities :**

-   Manage the **end‑to‑end lifecycle** of eTMFs, including setup, maintenance, and close‑out for clinical studies
-   Perform **regular quality control checks** to ensure document completeness, accuracy, and compliance with regulatory standards
-   Monitor and track **TMF metrics and KPIs** to ensure inspection readiness
-   Review and approve **TMF management plans** for internal teams and CROs
-   Act as a **Subject Matter Expert (SME)**, providing guidance and training on eTMF best practices
-   Develop, update, and maintain **SOPs, templates, and processes** related to TMF management
-   Serve as the **main point of contact** for eTMF-related queries, audits, and inspections
-   Ensure compliance of the eTMF system with **validation and regulatory requirements**
-   Manage **user access, system updates, and migrations**, and assess the impact of new system releases
-   Collaborate with IT teams to **resolve system issues and support continuous improvement**

## Requirements

-   **Education:** Bachelor’s or Master’s degree in **Health Sciences, Life Sciences, or related field**

-   **Experience:** **Strong experience** in clinical trial documentation management

-   **Technical Skills:**

\-Hands‑on experience with **Veeva Vault TMF** (mandatory)

\-Strong understanding of the **DIA TMF Reference Model**

\-Experience with **TMF metrics, KPIs, and dashboards**

-   **Knowledge:**

\-Strong knowledge of **ICH/GCP guidelines and regulatory requirements**

\-Understanding of clinical trial documentation lifecycle

\-Knowledge of cross‑functional stakeholders (Clinical, QA, PV, Biometry, etc.)

-   **Languages:** **Fluent English** (written and spoken)

## 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/9C5946A3EF/apply)

---
Powered by [Workable](https://www.workable.com)