Clinical Solution Architect, eTMF

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Excelya

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare Insurance • Pharmaceuticals • Biotechnology

Excelya is a leading global Contract Research Organization (CRO) focused on advancing healthcare through innovative solutions and expert guidance. With a presence in 28 countries, Excelya supports biotech, pharmaceutical, and medical device companies by offering full-service, functional service provider (FSP), and resourcing solutions across a broad spectrum of therapeutic areas. The company's unique business model emphasizes collaboration and flexible services, enabling clients to deliver life-changing therapies effectively.

📋 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 :** • - Led the implementation and configuration of Veeva Vault Clinical applications, including **eTMF, CTMS, Study Startup (SSU), Payments, and Site Connect**. • - Facilitated requirements gathering workshops and translated business needs into scalable and compliant system solutions. • - Designed and configured Vault solutions aligned with clinical operations processes and regulatory requirements. • - Managed system validation activities, including test planning, UAT coordination, defect tracking, and compliance documentation. • - Oversaw data migration and system integration projects, ensuring data quality and seamless interoperability with external systems. • - Developed and delivered end-user and administrator training programs, supporting user adoption and change management initiatives. • - Advised stakeholders on best practices, configuration options, and alternative solutions to optimize business processes and system performance. • - Partnered closely with client project teams across global pharmaceutical companies and SMEs to ensure successful project delivery and compliance with **ICH-GCP** and **GxP** standards.

🎯 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.