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Pierre Fabre

Allogeneic cell therapies development and commercialization

Medical Data Generation Project Manager - Studies, RWE

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A master's degree in sciences, a PhD, or pharmacist qualification is required.
  • At least 5 years of experience in clinical research monitoring and coordinating international real-world evidence (RWE) clinical studies in dermatology or pharmacare, within the pharmaceutical industry or a contract research organization (CRO).
  • Confirmed experience managing outsourcing and using performance indicators.
  • In-depth knowledge of International Council for Harmonisation (ICH) Good Clinical Practice (GCP), the regulatory environment, clinical study requirements and guidelines, and quality standards.
  • Knowledge of the expectations of internal partner functions, including biometrics, medical, quality assurance, regulatory affairs, and pharmacovigilance.
  • Fluent English, written and spoken.

Responsibilities

  • Manage resources and budgets needed to establish and monitor medical data generation projects.
  • Facilitate and coordinate project teams, ensure their effective operation, and lead implementation of project plans in line with the defined strategy.
  • Coordinate contributing functions within Pierre Fabre and subcontractors, including CROs, using appropriate tools such as responsibility and risk matrices, performance indicators, communication plans, and monitoring plans.
  • Manage project and study feasibility and CRO estimates with support from outsourcing managers.
  • With the Director of Medical Data Generation Projects, define and prepare oversight indicators and materials with the outsourcing manager for subcontracted activities, and report observed deviations or failures to the hierarchy and outsourcing manager.
  • Work with the medical writer to develop study protocols and other study documents.
  • Develop and implement project management practices to control project costs, timelines, and quality; incorporate risk-mitigation options; propose solutions to management for deviations and ensure approved solutions are implemented and monitored.
  • Ensure projects and studies comply with applicable Good Clinical Practice, operating procedures, and Pierre Fabre ethics and compliance rules.
  • Oversee administrative and document management for assigned studies.
  • Report operational and budget progress and required actions to the Director of the Medical Data Generation PMO to support transparent decision-making.
  • Protect participants' rights, safety, and well-being, and ensure study data are reliable and usable.
  • Supervise CROs responsible for studies, ensuring adherence to agreed quality, cost, and timeline criteria.

About the Company

Pierre Fabre

Allogeneic cell therapies development and commercialization

Pierre Fabre Pharmaceuticals (US) develops and commercializes allogeneic cell therapies for oncology and rare diseases. It focuses on bringing next-generation, donor-derived cell therapies to patients with high unmet medical needs and deepens partnerships with biotech companies to advance products through clinical manufacturing and distribution in the US.

Company size
5,001-10,000
Company stage
Seed
Total funding
$13.8M
Headquarters
Toulouse, France
Founded
1951

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