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PSI CRO

Clinical Operations Lead (Tokyo or Osaka)

Tokyo, Tokyo, JP · Hybrid · Full-time · Clinical

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About the role

JapaneseCommunication
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. In this role, you will build focus on line management and mentoring of Monitors on project-specific activities. Hybrid workstyle at either Tokyo or Osaka office.   The scope of responsibilities will include: - Prepare, conduct and report site selection, initiation, routine monitoring and closeout visits. - Act as a Mentor for the Monitors on project-specific activities and supporting their professional development. - Plan and conduct supervised monitoring visits with training, authorization, and ongoing assessment purposes. - Build and maintain good relationships with sites’ staff involved in the study conduct. - Contribute to the performance appraisal of monitors. - Training, coaching and mentoring the Clinical Operations team. - Supervise activities of Site Management Associates related to the flow of documents and laboratory supplies between the site and the Central/Regional Laboratory/Central Reviewer. - Development and implementation of quality control, ensuring data integrity and compliance at a site level. - Ensure proper handling, accountability and reconciliation of all Investigational Products and clinical study supplies. - Supports Clinical Operations Managers with resource allocation and utilization of departmental staff - Performs additional Clinical Operations supervisory tasks at the discretion of their Line Manager Qualifications College/University degree in Life Sciences or an equivalent combination of education, training & experience. - Minimum 2 years of CRA mentoring or training experience. - Full working proficiency in Japanese and English. - Ability to successfully mentor and train Clinical Operations staff. - Proficiency in MS Office applications. - Availability to travel (up to 60%). - Ability to plan and work in a dynamic team environment. - Communication, collaboration, and problem-solving skills. 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.