Clinical Solution Architect eTMF

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.