eTMF Specialist- CDI - H/F

INSTITUT DE RECHERCHE PIERRE FABRE SAS; Boulogne; On-site; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Competitive remuneration and benefits package

Incentives and profit-sharing

Health and provident insurance

16 days of RTT plus 25 personal days

Public transport participation

Job summary

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.

Responsibilities

• 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.

Skills

Clinical trial documentation management

TMF Veeva Vault

Knowledge of ICH/GCP

Regulatory requirements

Vendor oversight

Fluent English

Education

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

Tools

TMF Veeva Vault

Job description

About the Role

We are hiring a permanent eTMF Specialist based in Toulouse or Boulogne to support the Clinical Development Platform. The role reports to the Clinical Study Coordinators Manager in the R&D Medical Care department and focuses on managing the electronic Trial Master File (eTMF) system to ensure regulatory compliance, quality control and inspection readiness for global clinical trials.

Key Responsibilities

• Setup, maintenance and closeout of eTMFs, ensuring document completeness and compliance.
• Conduct regular quality control checks, monitor metrics and KPIs to verify regulatory standards.
• Approve TMF management plans for internal teams and CROs.
• Manage archive procedures to keep records accessible and organized.
• Act as the subject‑matter expert: provide training, support on best practices, develop and revise SOPs and templates, and serve as the primary contact for eTMF inquiries.
• Oversee IT system compliance: validate requirements, manage migrations and updates, handle study access, assess system version impacts and resolve issues in collaboration with IT teams.
• Support audits and inspections, ensuring readiness and documentation for external reviewers.
• Position permits teleworking up to two days a week after the trial period.

Qualifications

• Bachelor’s or master’s degree (or equivalent) in health sciences, life sciences or a related field.
• Minimum 5 years of experience in clinical trial documentation management, with at least 3 years in an eTMF‑focused role.
• Hands‑on experience with TMF Veeva Vault and other Veeva environments.
• Strong knowledge of ICH/GCP, regulatory requirements, the DIA TMF Reference Model and clinical trial documentation lifecycles.
• Experience with TMF metrics, KPIs and dashboards.
• Experience in vendor oversight and CRO collaboration is advantageous.
• Fluency in English (oral and written).

Benefits

Competitive remuneration and benefits package including incentives, profit‑sharing, shareholding participation with matching contributions, health and provident insurance, 16 days of holidays (RTT) plus 25 personal days, public transport participation, and additional attractive conditions.

Equal Employment Opportunity

At Pierre Fabre Laboratories we are committed to equal employment opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other legally protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and applicable state or local laws.