Chargement en cours

Clinical Project Manager M/F

PARIS, 75
il y a 8 heures
Design, implementation and coordination of clinical studies with the support of Clinical Operations, Pharmacovigilance, Biometrics and Medical Writing:
  • Plan the clinical development program
  • Prepare studies protocols, amendments and reports
  • Prepare regulatory dossiers
  • Manage relationships with investigators and opinion leaders
Requirements
  • Holder of additional training in methodology (CESAM, IUD, …)
  • Successful experience of Clinical Project Manager in a pharmaceutical company or CRO
  • 6-8 year’s experience in clinical development (Phase II and III)
  • Experience in oncology or autoimmune inflammatory diseases would be a plus
  • Experience in international development required
  • Experience of the regulatory environment for clinical trials
  • Experience of writing research reports and FDA regulatory dossiers (IND, NDA) and EMA
  • Based in Paris
  • Salary & package to define according skills and experience
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Entreprise
AB Science
Plateforme de publication
WHATJOBS
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