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Clinical Operations Lead (Tokyo or Osaka)

PSI CRO


Job Location:

Tokyo - Japan

Monthly Salary: Not provided by the employer
Posted: 3 July 2026 (30+ days ago)
Application Deadline: 30 September 2026
Vacancies: 1 Vacancy

Job Summary

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 :

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.


Remote Work :

No


Employment Type :

Full-time


About Company

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PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effo ... View more

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