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 throughout the study startup phase