In this role you will streamline activities of project teams and ensure consistency of Clinical Operations processes across Asia Pacific region. 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:
- Act as project management contact for the project team and PSI support services.
- 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.
- 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.
- Might be involved in regional project oversight for APAC.
