Clinical Operations Lead (Tokyo or Osaka)
PSI CRO · Tokyo
Company Description
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.
Job Description
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.