Job Description

Job Description

Take your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time. 

You will: 

  • Maintains study-specific and corporate startup tracking systems.
  • Facilitates site budgets and contract negotiations.
  • Supports site regulatory document collection.
  • Under supervision, may prepare initial and amendment submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable).
  • Communicates with the project team and investigational sites throughout the entire duration of the study.
  • Develops site specific startup timelines and is responsible for meeting the site activation milestones.
  • May review study specific translations.
  • Supervises Trial Master File (TMF) maintenance throughout the study startup phase.

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