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| Hiring Company | PSI CRO Japan株式会社 |
| Location | Tokyo - 23 Wards |
| Job Type | Permanent Full-time |
| Salary | 8 million yen ~ 12 million yen |
【求人No NJB2273480】
Responsibilities:
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) inJapan
・ 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
| Minimum Experience Level | No experience |
| Career Level | Mid Career |
| Minimum English Level | Business Level |
| Minimum Japanese Level | Native |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | Permission to work in Japan required |
・ 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 customer service skills
・ Team building leadership and organizational skills
・ Full working proficiency in English
・ Proficiency in MS Office applications including MS Project
| Job Type | Permanent Full-time |
| Salary | 8 million yen ~ 12 million yen |
| Work Hours | 09:00 ~ 18:00 |
| Holidays | 【有給休暇】初年度 最大10日(入社月によって異なる) 【休日】完全週休二日制 土 日 祝日 年末年始 |
| Industry | Contract Research Organization |
| Company Type | International Company |