eTMF Specialist- CDI - H/F

Pierre Fabre Pharmaceuticals Inc.; Toulouse; Sur place; EUR 50 000 - 70 000; Plein temps

Avantages offerts par ce poste

Incentives

Profit-sharing

Health insurance

25 days personal holidays

Public transport participation

Résumé du poste

Pierre Fabre Pharmaceuticals Inc. is seeking an eTMF Specialist for a full-time position in Toulouse. The specialist will oversee the eTMF system to ensure compliance, manage documentation, and support audits for global clinical trials.

The ideal candidate has at least 5 years of experience in clinical trial documentation management and a strong knowledge of ICH/GCP guidelines. This role offers an attractive remuneration package and up to 2 days of teleworking after the trial period.

Qualifications

• Minimum 5 years of experience in clinical trial documentation management.
• 3 years in an eTMF-focused role, ideally.
• Hands-on experience with Veeva environments.

Responsabilités

• Oversee the electronic Trial Master File (eTMF) system.
• Perform regular quality control checks.
• Ensure compliance with validation requirements.

Connaissances

Clinical trial documentation management

eTMF management

Veeva Vault

ICH/GCP guidelines

Project management

Formation

Bachelor’s or master’s degree in health sciences or related field

Outils

TMF Veeva Vault

Description du poste

eTMF Specialist- CDI - H/F page is loaded## eTMF Specialist- CDI - H/Flocations: Hauts-de-Seine (92): Haute Garonne (31)time type: Full timeposted on: Posted Todayjob requisition id: JR112769We are Pierre Fabre Laboratories, a global leader combining pharmaceutical expertise with dermo-cosmetics to support consumers and patients at every stage of their care journey. Our portfolio includes several medical franchises and international brands such as Eau Thermale Avène, Ducray, A-Derma, Klorane, René Furterer, and Pierre Fabre Oral Care. By joining us, you become part of a meaningful company where the human dimension is essential. You become a participant in the "We Care Movement," a movement that values excellence and innovation within passionate teams. Together, we push the boundaries of science to unite health and beauty for the benefit of all, because Every time we care for a single person, we make the whole world better. Present in 120 countries with a team of over 10,000 employees, we are proud to create a scientific and human impact, today and tomorrow! If caring is at the heart of your values, join Pierre Fabre Laboratories and become a key player in the “We Care Movement".# ****Your mission****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:*** **Key responsibilities in eTMF management:**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...# #**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.* Fluent English (oral and written).*At Pierre Fabre Laboratories, we believe that our greatest asset is our people.*We are committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identify, and maintain employment statistics on applicants. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process. Thus, we commit to considering all applications equally, without fail.