Job Title: Asia Pac Clinical Trial and Engagement Manager
Company: Jazz Pharmaceuticals
Location: Chiyoda-ku, JP – [Remote/Home-Based]
Category: Research & Development
Req ID: R010143
Brief Description
The Asia Pac Clinical Trial and Engagement Manager will oversee clinical studies in the Asia Pacific region, specifically focusing on the Republic of Korea and Japan. This role involves liaising with local CROs, site staff, and study investigators to drive the execution of clinical trials. Responsibilities include managing site engagement, ensuring timely study start-up, meeting patient enrollment targets, and maintaining strong relationships with key external experts in the region. The role requires leadership in clinical operations, vendor management, and ensuring compliance with regional regulations for Neurology and Oncology clinical trials.
Essential Functions/Responsibilities
Lead and oversee all company-sponsored studies in Korea, Japan, and other Asia Pacific countries.
Build and maintain influential relationships with key external experts, fostering a two-way exchange of scientific information.
Provide direction in CRO and vendor selection and management within the Asia Pacific region.
Ensure comprehensive oversight of all CRO and vendor activities, meeting timelines and budgets in collaboration with Global Clinical Development Operations (GCDO).
Lead site selection processes for clinical programs in Korea and Japan.
Manage study start-up activities and ensure aggressive but attainable timelines.
Monitor and achieve patient enrollment targets for regional studies.
Coordinate site engagement visits as necessary and ensure proactive site management.
Contribute to the development of clinical documents, such as protocols, monitoring plans, and clinical trial reports.
Manage local study budgets and ensure adherence to financial projections.
Qualifications
Education: Bachelor’s degree, nursing degree, or a health-related degree required (Life sciences degree preferred).
Experience: Minimum of 7 years in the pharmaceutical or biotechnology industry, with significant experience in Oncology clinical development highly preferred.
Skills:
Expertise in drug development and clinical trial operations in Korea and Japan.
Deep knowledge of ICH/GCP, Korean requirements, and Japan-GCP (J-GCP).
Experience in managing third-party vendors, CROs, central laboratories, and other clinical study vendors.
Proficiency in data management, drug safety, and pharmacovigilance.
Leadership skills to foster team productivity and cohesion.
Strong organizational and communication skills, both written and oral.
Fluency in Korean (spoken and written), and business proficiency in Japanese and English (fluent in both written and spoken Japanese and English preferred).
Travel: Willingness to travel frequently, including significant travel to the Republic of Korea.
Additional Information
Physical Demands: Frequent travel and computer usage.
Work Environment: Primarily office-based with interaction in a clinical setting.
Schedule: Requires flexibility to accommodate travel and varying business demands.
Compensation
Benefits: Eligible for medical, dental, and vision insurance, retirement savings plans, and flexible paid vacation.
For more information about benefits, please visit: Jazz Benefits.
Jazz Pharmaceuticals is an equal opportunity employer.
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