Head of Clinical FSPx, Japan

Job Location(s) JP-Tokyo
Job Number
Job Category
Clinical Operations Management
Position Type

Job Overview

- Responsible for the supervision of assigned direct reports within Clinical Operations, FSPx and/ or Sub-CRO Services Staff
- Responsible for detailed performance review and management of assigned direct reports including: Annual Performance Management and Development (PMD), Individual Development Plan (IDP), Line of Sight Goals and "Shoves & Tugs"
- Responsible for appropriate management and resolution of performance issues
- Development and measure performance indicators for assigned staff
- Identify individual training needs and assist with the coordination and conduct of training and development efforts, globally
- Recommend and coordinate appropriate training initiatives to ensure compliance with policies and procedures, globally
- Coordinate, conduct, report and follow-up on Quality Control Visits (CQC)
- Effectively communicate and develop management strategies, policies and procedures in conjunction with leadership teams
- Develop and maintain effective relationships with management team to manage assigned staff in a matrix environment
- Develop and maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business
- Responsible for Contract CRA on-boarding, management and off-boarding
- Responsible for financial negotiation and management of Contract CRA vendors


- English required: Speaking, Writing, Reading
- University degree- life sciences preferred or certification in  a relating allied health profession from an appropriately accredited institution (e.g/., nursing certification, medical or laboratory technology)
- Preferred: Masters or other advanced degree


- Relevant clinical research experience in a pharmaceutical company or CRO
- Individual is proficient with on sited monitoring activities (including pre-study, initiation, routine monitoring and closeout visits)
- Minimum of nine years relevant clinical research experience in a pharmaceutical company/CRO
- Through knowledge of drug development process
- Through knowledge of relevant SOPs, ICH, and GCP guidelines

- Relevant supervisory experience
- Minimum of 5 years as a Line Manager or Project Manager required
- Demonstrated ability to lead by example and encourage team members to seek solutions
- Proven interpersonal skills
- Demonstrated ability to successfully participate as a member of a project team
- Demonstrated ability to successfully manage multiple competing priorities
- Advanced planning and organizational skills
- Advanced oral, written and presentation skills both in Japanese and English


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