Clinical Project Manager - Innovative Gene Therapy Start Up

Responsibilities

  • Lead, manage and co-ordinate the conduct of assigned clinical trials from study start-up to close out in accordance with ICH-GCP
  • Oversees the quality of the clinical operations for the studies he/she is in charge of 
  • Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
    • Coordinates medical writing and all the activities necessary for delivering of documentation: publishing, QC, etc
    • Manages data management and statisticians ensuring data base maintenance, database lock, etc
    • Manages clinical sites and academics institutions, ensures adherence for keeping clinical records, source documents, data entry, manages clinical trial logistics, applications (IRB, local agencies)
  • Planning, management and reporting of clinical studies through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables
  • Ensuring implementation and conduct of study(ies) in accordance with ICH-GCP guidelines
    • Ensures development, review, finalization and delivery of high quality key study documents in order to meet study timelines.
    • Manages CRFs creation, implementation, ensuring data management is properly for the study activities
    • Ensures accurate maintenance and archiving of study records
    • Oversees (e)TMF
  • Management of study budget and timelines
  • Management of vendors to the required standards
  • Strong knowledge of clinical project management
  • Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
  • Understanding of regulatory environment, GCP/ICH
  • Experience working in an academic environment is a plus, as well as experience in orphan disease field
  • Other activities as may be assigned

Education

  • Msc/PhD in life sciences (preferred)