SAS II
Hybrid · Osaka, Osaka, Japan or Tokyo, Tokyo, Japan
Job Summary
Country Start-Up responsibilities include managing local submissions and regulatory applications (EC/RA), ensuring site activation, maintaining trial master file metadata, and coordinating with the country start-up advisor and SAM. The role requires preparing ongoing submissions and amendments, liaising with investigators and vendors, and ensuring regulatory compliance across country-level activities. Requires a Bachelor’s Degree and strong knowledge of clinical trial start-up processes and ICH GCP; operates in a Hybrid capacity in Tokyo and Osaka, Japan.
Required Qualifications
- Bachelor’s Degree
- Detailed understanding of clinical trial process across Phases II-IV and ICH GCP
- Detailed understanding of clinical trial start-up processes
- Ability to manage external vendors to contract effectively
- Strong organizational skills with ability to handle multiple tasks effectively
- Strong written and verbal communication and interpersonal skills
- Ability to manage multiple project budgets with increased complexity and value
- Quality-driven in all managed activities
- Good negotiating skills
- Good problem-solving skills
- Demonstrated ability to work independently as well as part of a team
This role has closed. Sorce can match you with similar open roles and apply on your behalf.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.