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 thirdparty 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 studyspecific 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 projectspecific 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
Qualifications :
- MPharm RN or university/college degree in Life Sciences or an equivalent combination of education training and experience
- Minimum 4 years site monitoring experience in Japan
- At least 2 years experience as Lead Monitor
- Experience supervising clinical project activities and leading clinical project teams
- Experience in oncology gastroenterology infectious diseases autoimmune diseases or any rare disease indication is preferable
- Communication presentation and customerservice skills
- Team building leadership and organizational skills
- Full working proficiency in English
- Proficiency in MS Office applications including MS Project
Additional Information :
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
Remote Work :
No
Employment Type :
Fulltime