Manager d'Etudes Cliniques CDI- HF
Job Summary
Who we are
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 10000 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
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 vendors 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...
Who you are
Your skills at the service of innovative projects:
You hold a postgraduate scientific degree (Masters 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 companys 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.
Required Experience:
Manager
About Company
"We are developing the drugs and care of tomorrow with the inexhaustible resources of our imaginations" Mr. Pierre Fabre