eTMF Solutions Architect for Global Clinical Trials

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

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.