Clinical Solution Architect eTMF

Excelya; Paris; Hybride; EUR 60 000 - 85 000; Plein temps

Avantages offerts par ce poste

None

Résumé du poste

Excelya seeks an eTMF Specialist to ensure the quality, compliance, and inspection readiness of the electronic Trial Master File across global clinical trials.

Role requires strong expertise in clinical documentation management, collaboration with cross-functional teams, and active involvement in audits within a regulated environment. Fluent English is essential.

Qualifications

• Bachelor’s or Master’s degree in Health Sciences, Life Sciences or related field.
• Strong experience in clinical trial documentation management and eTMF systems.
• Solid understanding of ICH-GCP guidelines and regulatory requirements.

Responsabilités

• 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, 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 interoperability.
• Developed and delivered end-user and administrator training programs to support adoption and change management.
• Advised stakeholders on best practices and configuration options to optimize process performance.
• Partnered with client project teams to ensure project delivery and compliance with ICH-GCP and GxP standards.

Connaissances

Clinical documentation management

Audit readiness

Regulatory compliance

Cross-functional collaboration

Veeva Vault knowledge

Formation

Bachelor’s or Master in Health/Life Sciences

Outils

Veeva Vault TMF

Veeva Vault CTMS

Veeva Vault SSU

Description du poste

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.

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)

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’sleading mid-size CROwith thebest employee experience. Ourone-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.