Clinical Research Associate (all Level)

BeOne Medicines

Japan, Japan
**
Ich guidelines and gcp
Oncology clinical trials
Clinical trial site contract negotiation
** BeOne Medicines is seeking a Clinical Research Associate (CRA) at all levels to oversee and monitor clinical trials in Japan, focusing on oncology. The role emphasizes collaboration, regulatory compliance, and effective communication with clinical sites to ensure timely and quality execution of studies. **

Job Summary

  • The CRA executes clinical trial protocols at clinical trial sites and monitors clinical trials by ICH guidelines and GCP, local regulations, and applicable SOPs.
  • Accountable for the study start-up timelines and delivery, including investigator/site identification, IRB/EC submissions, and site contract/budget negotiation.
  • Supports the build-out of the Japan organization and required processes, including preparing for and supporting PMDA inspections.

Matching Summary

Match Score: 75

** BeOne Medicines is seeking a Clinical Research Associate (CRA) at all levels to oversee and monitor clinical trials in Japan, focusing on oncology. The role emphasizes collaboration, regulatory compliance, and effective communication with clinical sites to ensure timely and quality execution of studies. **

Skills & Requirements

Must-have

  • ICH guidelines and GCP
  • Oncology clinical trials
  • Clinical trial site contract negotiation
  • Trial Master File (TMF) management
  • PMDA inspection support

Nice-to-have

  • Scientific and business professionals
  • Highly motivated and collaborative
  • Passionate interest in fighting cancer
  • Proactive issue identification and resolution

Key Requirements

  • BS in a relevant scientific discipline
  • At least 3 years monitoring experience
  • Experience in oncology global trials preferred
  • Fluent in English (writing and speaking)

Work Rights

Not specified

Tailored Resume

Cover Letter