Job Details


・Manage approximately 60 CRAs
・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)
・Hold Cosource staff accountable for quality and compliance with client SOPs and
adherence to Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables
・Coach assigned staff to own effective Investigator relations and Investigator oversight at the local level


・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 9 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
・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
<Education/Qualifications/Certifications and Licenses>
・University/college degree: life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
・In lieu of this required educational background the following relevant work history may be considered: Minimum of 7 years supervisory experience in a health care or clinical research setting and Minimum of 11 years relevant clinical research experience in a pharmaceutical company/CRO
・Masters or other advanced degree
<Travel Requirements>
・30% of travel by plane and car as required with overnight and domestic/potential international travel
・Ability to drive and have a valid driver’s license as appropriate per country travel norms
<Language Skills Required>
・Speaking: English and Local Language required
・Writing/Reading: English and Local Language required



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