Clinical Operations Lead (Tokyo or Osaka) at PSI CRO

Tokyo, , Japan -

Full Time

Start Date

Immediate

Expiry Date

30 Sep, 26

Salary

0.0

Posted On

02 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Line Management, Mentoring, Clinical Monitoring, Site Selection, Site Initiation, Closeout Visits, Quality Control, Data Integrity, Investigational Product Handling, Resource Allocation, Japanese Proficiency, English Proficiency, MS Office, Problem Solving, Collaboration, Communication

Industry

Pharmaceutical Manufacturing

Description

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.

Responsibilities

The role focuses on the line management, mentoring, and training of Clinical Operations staff and monitors. Responsibilities include conducting site visits, ensuring data integrity and compliance, and supporting resource allocation.