Clinical Operations Lead (Tokyo or Osaka)
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
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