Clinical Operations Lead (Tokyo or Osaka)

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.