Clinical Research Site Manager

CellProthera is a biotech company based in Mulhouse (FR) developing innovative cell therapy products based on a proprietary cell processing technology platform. A multi-center Phase I/IIb clinical trial is currently on-going in Europe to test the therapy product Protheracytes®  (ATMP) in patients having suffered from severe acute myocardial infarction.

YOUR MISSION

Under supervision of the Medical Director and in close collaboration with the members of the Medical Team, you are actively managing the research sites in Europe to ensure the good conduct of the clinical trial, according to the study protocol, the clinical guidelines and the planning.  Your main duties and responsibilities are:

  • Carry out regular site visits including site selection, site training, recruitment follow-up, data monitoring and initiation/close-out visits – mainly in France & UK
  • Verify accuracy and completeness of site data in agreement with source documents
  • Monitor and manage performance of each research site against objectives and provide sufficient updates on trial progress to the Medical Director
  • Develop long-term, trust relationship with research teams and investigators by providing them superior support and services in order to maintain their commitment to the study and maximize patients’ recruitment
  • Work with the Medical and Regulatory teams to ensure quick completion of regulatory pathway and new site approval
  • Follow and coordinate field activities of the CRO
  • Work on design and update of clinical procedures in collaboration with the Medical Team

YOUR PROFILE

  • Scientific qualification (minimum Bachelor’s degree) in Life Sciences
  • A minimum of 3 years’ experience in clinical research or equivalent, preferably CCRA
  • Field experience in clinical operations, working directly with medical doctors and research associates, preferably at sponsor and in the cardiovascular field
  • Familiar with clinical regulation and industry standards
  • Excellent presentation and communication skills
  • Ability to work in autonomy in a demanding regulatory environment
  • Hard-worker, rigorous and result-oriented
  • Ability to travel domestically and internationally (60-80%)
  • English fluent. French conversational

 

Applicants should also be entitled to work within the European Economic Area (EEA).

Position in Mulhouse (Fr) or home based in France or UK , preferably in a well-connected location. If you are interested in this job, please contact Paula Lee (plee@cellprothera.com)