Clinical Solution Architect eTMF

Excelya; Paris; Sur place; EUR 65 000 - 85 000; Plein temps

Résumé du poste

Excelya is seeking an eTMF Specialist to ensure quality, compliance, and inspection readiness of the electronic Trial Master File across global trials. You will manage TMF configurations, validation activities, data migrations, and cross-functional collaboration with QA, Clinical, PV, and Biometry.

The role requires hands-on TMF expertise, strong regulatory knowledge, and fluent English for global communications.

Qualifications

• Education in health or life sciences is required.
• Strong experience with clinical trial documentation management.
• English fluency is essential for written and spoken communication.

Responsabilités

• Lead configuration and deployment of Veeva Vault TMF and related applications.
• Coordinate requirements workshops and translate needs into compliant solutions.
• Configure Vault to align with regulatory and clinical operations processes.
• Manage validation activities, including testing, UAT, and documentation.
• Oversee data migration and integration with external systems.
• Develop end-user and admin training for system adoption.
• Advise stakeholders on best practices and optimization opportunities.
• Collaborate with global project teams to ensure audit readiness and compliance.

Connaissances

Clinical documentation management

Cross-functional collaboration

Regulatory compliance

Formation

Bachelor's or Master's degree in Health Sciences/Life Sciences

Outils

Veeva Vault TMF

DIA TMF Reference Model

TMF dashboards

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

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.