We 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".
The Clinical Operations Team from Pierre Fabre Pharma R&D is recruiting a Clinical Study Manager (CSM) either based in Boulogne-Billancourt (Paris area) or in Toulouse (South-West of France).
Pierre Fabre sponsors international interventional clinical trials from Phase I (first-in-human) to Phase IV across its key therapeutic areas: primarily oncology, dermatology, and rare diseases.
You will join a team of around 18 people led by the Director of Clinical Operations and will be responsible for the set-up and conduct of assigned clinical studies. You will lead Clinical Trial Teams and coordinate all internal and external stakeholders to ensure study delivery in line with quality, cost, and timeline objectives.
Your role within a pioneering company in full expansion:
- Acting as Project Manager for your studies, coordinating and supervising internal teams and external vendors (CROs) using appropriate project management and performance monitoring tools (e.g. risk matrix, responsibility matrix, key performance indicators, communication plan, monitoring plan, etc...).
- Overseeing study feasibility and budget estimates prepared by CROs, with support from Outsourcing Managers.
- In collaboration with the Director of Clinical Operations, within the framework of study outsourcing: defining and preparing, together with Outsourcing Manager, all performance indicators and oversight tools used to monitor vendor's activities and reporting to management and Outsourcing Manager any deviations or non-compliance observed with regards to contractual commitments.
- Contributing to protocol in close collaboration with the Medical writer as well as developing study documents.
- Leading the Clinical Trial Team for your assigned studies.
- Ensuring studies are optimised and controlled in terms of cost, timelines, quality, and risk management, and proposing corrective actions when required along with monitoring their implementation.
- Ensuring full compliance with Good Clinical Practice, internal procedures, and Pierre Fabre ethical standards.
- Supervising study administrative and document management activities performed by Clinical Study Coordinators.
- Reporting study progress and budget status to project and clinical operations management.
- Acting as a mentor and reference for junior Clinical Study Managers.
The role involves occasional national and international travels.
This position is compatible with teleworking up to 2 days a week according to company rules.
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...
Your skills at the service of innovative projects:
You hold a postgraduate scientific degree (Master’s level or equivalent) in medicine, pharmacy, or another scientific discipline, and have at least 5 years’ experience managing international clinical trials.
Experience in oncology would be an asset.
You have a proven track record of successful collaborations with international CROs on strategic, project-based studies and have a strong understanding of the clinical regulatory and quality environment.
You are fluent in English, both spoken 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.