Manager d'Etudes Cliniques - CDI- H/F

Responsibilities

• Act as Project Manager, coordinating and supervising internal teams and external vendors (CROs) using project management tools such as risk matrix, responsibility matrix, KPIs, communication plan, monitoring plan, etc.
• Oversee study feasibility and budget estimates prepared by CROs, with support from Outsourcing Managers.
• Define and prepare performance indicators and oversight tools for vendor activities, and report deviations or non‑compliance to management and the Outsourcing Manager.
• Contribute to protocol development in close collaboration with the medical writer and develop study documents.
• Lead the Clinical Trial Team for assigned studies.
• Ensure studies are optimised and controlled in terms of cost, timelines, quality, and risk management, proposing corrective actions and monitoring their implementation.
• Ensure full compliance with Good Clinical Practice, internal procedures, and Pierre Fabre ethical standards.
• Supervise study administrative and document management activities performed by Clinical Study Coordinators.
• Report study progress and budget status to project and clinical operations management.
• Act as mentor and reference for junior Clinical Study Managers.

Occasional national and international travel may be required. The position is compatible with teleworking up to two days per week according to company rules.

Benefits

Incentives, profit‑sharing, shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) plus 25 personal holidays, and public transport participation.

Qualifications

• Postgraduate scientific degree (Master’s level or equivalent) in medicine, pharmacy, or a related scientific discipline.
• At least 5 years of experience managing international clinical trials, with a proven track record of successful collaboration with international CROs on strategic, project‑based studies.
• Strong understanding of the clinical regulatory and quality environment.
• Fluency in English (spoken and written).
• Experience in oncology is an asset.

Equal Employment Opportunity

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 recognised protected basis under federal, state, or local law.

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