Clinical Operations Lead (Tokyo or Osaka)

PSI CRO AG · Tokyo, Japan · full-time · Hybrid · July 02, 2026

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Posted July 02, 2026 · Read from PSI CRO
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Job Description

In this role, you will build focus on line management and mentoring of Monitors on project-specific activities.

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

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.

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.

Employer
PSI CRO AG
Location
Tokyo, Japan · Hybrid
Contract
full-time