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Study Startup Specialist II (~Senior level).

PSI

Oshima, Tokyo, Japan Full-time May 28, 2026
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Opportunity Description

Job Description

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

Office based in Tokyo or Osaka

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 submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable)
  • Communicates with the project team and investigational sites throughout the study startup phase
  • Develops site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestones
  • May review study specific translations
  • Supervises Trial Master File (TMF) maintenance throughou...
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