In this role you will streamline activities of project teams in Japan and ensure consistency of Clinical Operations processes across regions. You will ensure meeting study milestones by project teams on a country level, report study progress to clients and global stakeholders.
The scope of responsibilities will include:
- Coordinate project team work in Japan
- Act as project management contact for the project team and PSI support services
- Act as a contract for global clients, contractors, subcontractors and third-party vendors
- Perform study status review and progress reporting, collect and report project status updates
- Develop and update project planning documents, essential study documents and project manuals/ instructions
- Supervise clinical project team performance, manage, and report on Key Performance Indicators (KPIs) in Japan
- Ensure that the project timelines and subject enrollment targets are met
- Coordinate maintenance of study-specific and corporate tracking systems
- Oversee site selection and startup, site contractual and budget negotiations
- Supervise project team and site training, perform field training of monitors tailored to the project needs
- Ensure team compliance with project-specific training matrix
- Supervise preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits
- Review site visit reports and ensures monitoring and reporting standards are met
- Oversee investigator and site payments
- Supervise project team preparation for study audits/ inspections and resolution of audit/ inspection findings