eTMF Specialist

Pierre Fabre Laboratories; Boulogne-Billancourt; Hybride; EUR 65 000 - 85 000; Plein temps

Avantages offerts par ce poste

Profit sharing

Shareholding plan

Health insurance

Transport allowance

Paid holidays

Résumé du poste

Pierre Fabre Laboratories is hiring a permanent eTMF Specialist to join the R&D Medical Care department in Toulouse or Boulogne. You will oversee the eTMF system to ensure regulatory compliance, quality control, and inspection readiness across global clinical trials.

The role requires expertise in clinical trial documentation management, cross-functional collaboration, and active participation in audits and inspections. Remote work is possible up to 2 days per week after the trial period.

Qualifications

• Minimum 5 years in clinical trial documentation management.
• 3+ years in an eTMF-focused role.
• Strong knowledge of ICH/GCP, regulatory standards and TMF lifecycles.
• Experience with TMF metrics, KPIs and dashboards.

Responsabilités

• Oversee setup, maintenance and closeout of eTMFs across trials.
• Monitor document completeness and compliance; ensure inspection readiness.
• Provide SME training and develop SOPs/templates for eTMF.
• Support audits/inspections and collaborate with CROs and internal teams.
• Coordinate system migrations and validation activities with IT.

Connaissances

eTMF management

Regulatory compliance

Quality control

Cross-functional collaboration

Audit support

Formation

Bachelor's or Master's in health sciences

Outils

Veeva Vault

Description du poste

We are hiring a permanent eTMF Specialist in Toulouse or Boulogne to join a team of 7 people under the hierarchical and functional responsibility of the Clinical Study Coordinators Manager in the R&D Medical Care department.

The eTMF Specialist plays a vital role within the Clinical Development Platform by overseeing the electronic Trial Master File (eTMF) system to ensure regulatory compliance, quality control, and inspection readiness across global clinical trials.

This position requires expertise in clinical trial documentation management, collaboration with cross-functional teams, and active participation in audits and inspections.

Your role within a pioneering company in full expansion:

The specialist manages the setup, maintenance, and closeout of eTMFs, performs regular quality control checks, monitors metrics and KPIs to ensure document completeness and compliance, and approves TMF management plans for internal teams and CROs. They also handle archive management to maintain accessible and organized records.

Subject Matter Expert role:

They serve as the SME by providing training and support on eTMF best practices, developing and revising related SOPs and templates, and acting as the main contact for eTMF-related queries from users, auditors, and other stakeholders.

IT system oversight and compliance:

The specialist ensures compliance with validation requirements, manages system migrations and updates, creates and manages study access, assesses the impact of new system versions, and supports problem resolution and system evolution in collaboration with IT teams.

DIMENSIONS, CONTEXT AND IMPLICATIONS OF THE JOB

The clinical trials are mainly international and covered the therapeutic areas from Pierre Fabre portfolio, namely oncology, dermatology and rare diseases. A high level of quality and accuracy is expected by the eTMF specialist.

This position is compatible with teleworking up to 2 days a week after the trial period.

We offer an attractive remuneration/benefits package: Incentives, profit-sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) in addition to 25 days of personal holidays, public transport participation, very attractive CE...

Level of training/Background

Your skills at the service of innovative projects:

• Bachelor's or master's degree or equivalent in a 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, guidelines, quality standards and regulatory requirements.
• Strong understanding of the DIA TMF Reference Model and clinical trial documentation lifecycles.
• Knowledge of internal stakeholders' expectations (biometry, medical, quality assurance, clinical development, pharmacovigilance, etc...).
• Experience with TMF metrics, KPIs, and dashboards.
• Experience in vendor oversight and CRO collaboration are advantageous.