Study Startup Specialist II (~Senior level).

PSI · Oshima, Tokyo, Japan

Location

Oshima

Job Type

Full-time

Posted

June 09, 2026

Job 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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