Clinical Solution Architect, eTMF

This is a fully remote position, open to applicants in France.

📋 Description

• Become a part of Excelya, a vibrant and innovative organization dedicated to excellence and collaboration in the realm of translational research.

• The **eTMF Specialist** is integral to the Clinical Development Platform, ensuring the **quality, compliance, and inspection readiness** of the electronic Trial Master File (eTMF) across international clinical trials.

• This position necessitates a robust expertise in **clinical documentation management**, close cooperation with cross-functional teams, and active participation in audits and inspections within a regulated setting.

• **Key responsibilities :**

• - Spearheaded the implementation and configuration of Veeva Vault Clinical applications, including **eTMF, CTMS, Study Startup (SSU), Payments, and Site Connect**.

• - Conducted requirements gathering workshops, translating business needs into scalable and compliant system solutions.

• - Crafted and configured Vault solutions in line with clinical operations processes and regulatory standards.

• - Managed system validation activities, encompassing test planning, UAT coordination, defect tracking, and compliance documentation.

• - Supervised data migration and system integration projects, ensuring data quality and seamless interoperability with external systems.

• - Developed and facilitated training programs for end-users and administrators, supporting user adoption and change management initiatives.

• - Provided guidance to stakeholders on best practices, configuration options, and alternative solutions to enhance business processes and system performance.

• - Collaborated closely with client project teams from global pharmaceutical companies and SMEs to ensure successful project delivery and adherence to **ICH-GCP** and **GxP** standards.

⛳️ Requirements

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

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

• - **Technical Skills:**

• - Proficient hands-on experience with **Veeva Vault TMF** (mandatory).

• - Comprehensive understanding of the **DIA TMF Reference Model**.

• - Familiarity with **TMF metrics, KPIs, and dashboards**.

• - **Knowledge:**

• - In-depth knowledge of **ICH/GCP guidelines and regulatory requirements**.

• - Understanding of the clinical trial documentation lifecycle.

• - Awareness of cross‑functional stakeholders (Clinical, QA, PV, Biometry, etc.).

• - **Languages:** **Fluent in English** (both written and spoken).

🏝️ Benefits

• **Why Join Us?**

• At Excelya, we merge our passion for science with a commitment to teamwork to redefine excellence in healthcare.

• Here’s what sets us apart—

• We are a youthful, ambitious health company comprising 900 Excelyates, striving 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—allows you to grow through diverse projects. Collaborating with leading experts, you will enhance scientific, operational, and human knowledge to improve the patient's journey.

• **Excelling with care** signifies thriving in an environment that appreciates your innate talents, challenges norms with courage, and fosters your potential, enabling you to fully contribute to our collective mission.