eTMF Specialist — Remote/Hybrid, Compliance & Training

INSTITUT DE RECHERCHE PIERRE FABRE SAS; Boulogne; Hybride; EUR 50 000 - 70 000; Plein temps

Avantages offerts par ce poste

Competitive remuneration and benefits package

Incentives and profit-sharing

Health and provident insurance

16 days of RTT plus 25 personal days

Public transport participation

Résumé du poste

INSTITUT DE RECHERCHE PIERRE FABRE SAS is looking for a permanent eTMF Specialist based in Toulouse or Boulogne. This role is vital for managing the electronic Trial Master File (eTMF) to ensure regulatory compliance and quality control for global clinical trials.

The successful candidate will be responsible for setup, maintenance, and oversight of eTMFs, conducting quality checks, and supporting audits. A degree in health or life sciences and significant experience in clinical trial documentation is required. The position also allows teleworking up to two days a week post-trial period.

Qualifications

• Minimum 5 years of experience in clinical trial documentation management.
• At least 3 years in an eTMF‑focused role.
• Hands‑on experience with TMF Veeva Vault and other Veeva environments.

Responsabilités

• Setup, maintenance and closeout of eTMFs ensuring document compliance.
• Conduct regular quality control checks to verify regulatory standards.
• Provide training and support on eTMF best practices.
• Oversee IT system compliance in collaboration with IT teams.

Connaissances

Clinical trial documentation management

TMF Veeva Vault

Knowledge of ICH/GCP

Regulatory requirements

Vendor oversight

Fluent English

Formation

Bachelor’s or master’s degree in health sciences or life sciences

Outils

TMF Veeva Vault

Description du poste

INSTITUT DE RECHERCHE PIERRE FABRE SAS is looking for a permanent eTMF Specialist based in Toulouse or Boulogne. This role is vital for managing the electronic Trial Master File (eTMF) to ensure regulatory compliance and quality control for global clinical trials.

The successful candidate will be responsible for setup, maintenance, and oversight of eTMFs, conducting quality checks, and supporting audits. A degree in health or life sciences and significant experience in clinical trial documentation is required. The position also allows teleworking up to two days a week post-trial period.