[2021-09] Clinical project manager (M/W)

[2021-09] Clinical project manager (M/W)

Clinical project manager (M/W)

CellProthera is a biotech company based in the BioValley, one of the leading life science clusters in Europe. It develops 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 treat patients having suffered from severe acute myocardial infarction.

Your mission

Reporting to the Medical director, you will participate in the execution of clinical trial(s), with focus on supervising monitoring and site management activities to ensure deliverables are on-time and on-budget You will lead projects assigned to you and coordinate cross-functional project teams.

Your tasks: :

  • Plan and manage the project timelines and resources including management of vendors. Proactively anticipate and understand concerns/issues/delays in the project and develop risk assessment and contingency plans
  • Build and maintain strong relationships with clinical sites, investigators and clinical research associates
  • Prepare, conduct and report on activities related to the completion of site selection, initiation, routine monitoring and close-out visits
  • Monitor patient enrolment to ensure recruitment targets and project timelines are met at the site and/or country level
  • Ensure proper handling, accountability and reconciliation of all Investigational Product(s) and clinical study supplies
  • Review the status and contents of essential documents at the site level and reconcile study OSF/ TMF at site and/or country level
  • Maintain all appropriate project documentation according to processes, procedures (Company’ SOPs) and regulatory requirements (ICH GCP)

Profil :

  • At least 10 years’ experience in clinical operations in the pharma industry or equivalent with a minimum of 5 years’ experience in site monitoring and/or clinical trial management
  • Master degree or equivalent in a scientific or health related field
  • Excellent communication skills, both verbal and written, are required
  • English proficiency, French conversational
  • Must have effective time management and organizational skills, ability to solve problems
  • Regular travel to sites
  • Proficient in MS Office Products (Word, Excel, PowerPoint)

Applicants should also be entitled to work within the European Economic Area (EEA) and willing to travel regularly. Position in Mulhouse (France), open to home office. If you are interested in this job, please send your application documents to Paula LEE (plee@cellprothera.com)

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