BeOne Medicines Ltd is seeking a Regional Clinical Study Manager for their Japan office, focusing on managing clinical trials and ensuring compliance with local regulations. The ideal candidate should have extensive experience in clinical research, particularly in the biotech or pharmaceutical sectors, and demonstrate strong leadership skills
Job Summary
Supports Senior Director to build Japan organization and required process such as Local SOP and WI.
Leads all aspects of assigned clinical trial(s) and demonstrates a high level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilities.
Market competitive compensation package including performance-based annual bonus scheme, company shares, and fantastic benefits program.
Matching Summary
Match Score: 85
BeOne Medicines Ltd is seeking a Regional Clinical Study Manager for their Japan office, focusing on managing clinical trials and ensuring compliance with local regulations. The ideal candidate should have extensive experience in clinical research, particularly in the biotech or pharmaceutical sectors, and demonstrate strong leadership skills.
Skills & Requirements
Must-have
Clinical trial management methodologies
Vendor management for FSP
Adherence to ICH guidelines
Site motivation and oversight visits
PMDA inspection preparation
Nice-to-have
Collaborative and motivated professionals
Passionate interest in fighting cancer
Continuous learning and development
Key Requirements
5 years or above of progressive experience in clinical research
Bachelors degree or higher in a scientific or healthcare discipline
Fluent in English
Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines