Clinical Site Manager II（臨床開発モニター/ Site Monitor/ CRA）

A Clinical Site Manager II (CSM II) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure.

Requirements

• BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience.
• Five years site monitoring and/or site management experience.
• A minimum of 2 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant therapeutic area experience.
• Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong critical thinking and problem solving skills.
• Strong IT skills in appropriate software and company systems.
• Willingness to travel up to 40% with overnight stay away from home.
• Proficient in speaking and writing English.

Benefits

• Annual paid leave
• Childcare leave system
• Nursing care leave system
• Employment Insurance
• Industrial Accident Compensation Insurance
• Welfare Pension Insurance
• Health Insurance
• Mutual Aid Association System
• Company Housing System
• Employee Shareholder Association System
• Property Accumulation Savings System