eTMF Specialist: Remote-Friendly Global Trials & Audits

Pierre Fabre Group; Toulouse; Hybride; EUR 55 000 - 75 000; Plein temps

Avantages offerts par ce poste

Incentives

Profit sharing

Shareholding with matching contrib.

Health insurance

Provident insurance

RTT 16 days + 25 personal holidays

Public transport allowance

Résumé du poste

Laboratoires Pierre Fabre recherche un(e) eTMF Specialist en Toulouse ou Boulogne, rattaché au Manager Clinical Study Coordinators dans le département R&D Medical Care. Vous supervisez le système eTMF pour assurer la conformité, le contrôle qualité et l'inspection readiness à l’échelle mondiale.

Vous collaborez avec les équipes transverses, assurez la gestion documentaire des essais et participez aux audits.

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, guidelines, quality standards and regulatory requirements.
• Fluent English (oral and written).

Responsabilités

• Manage the setup, maintenance and closeout of eTMFs, perform regular quality control checks, monitor metrics and KPIs to ensure document completeness and compliance, and approve TMF management plans for internal teams and CROs.
• Handle archive management to maintain accessible and organized records.
• Serve as SME by providing training and support on eTMF best practices, developing and revising related SOPs and templates, and acting as main contact for eTMF-related queries.
• Ensure compliance with validation requirements, manage system migrations and updates, create and manage study access, assess impact of new system versions, and support problem resolution with IT teams.
• Support international trials across therapeutic areas (oncology, dermatology, rare diseases) and participate in audits/inspections.

Connaissances

English fluency

Regulatory knowledge

Documentation management

Formation

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

Outils

Veeva Vault TMF

Description du poste

Laboratoires Pierre Fabre recherche un(e) eTMF Specialist en Toulouse ou Boulogne, rattaché au Manager Clinical Study Coordinators dans le département R&D Medical Care. Vous supervisez le système eTMF pour assurer la conformité, le contrôle qualité et l'inspection readiness à l’échelle mondiale.

Vous collaborez avec les équipes transverses, assurez la gestion documentaire des essais et participez aux audits.