This role manages study documentation and operational progress using CTMS, ensuring the highest quality standards in clinical study execution
Job Summary
This role manages study documentation and operational progress using CTMS, ensuring the highest quality standards in clinical study execution.
The position oversees documentation and study management support across various clinical studies, ensuring compliance with regulations and SOPs.
Leveraging CRA experience, this role provides an opportunity to oversee clinical studies from a broader perspective and support both operational and quality aspects.
Matching Summary
This role manages study documentation and operational progress using CTMS, ensuring the highest quality standards in clinical study execution.
Skills & Requirements
Must-have
Clinical Trial Management System (CTMS)
TMF documentation management
GCP compliance
ISO14155 compliance
Fluent in English and Japanese
Nice-to-have
Proactive problem-solving
Continuous process improvement
Team collaboration
Mentoring junior staff
Key Requirements
Bachelor’s degree or equivalent
>2 Years of Field Clinical Research Associate experience