- Remote, Vietnam
- Remote
- 5+ years
Responsibilities
- Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP.
- Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan.
- Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents.
- Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central).
- May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required.
Requirements
- Bachelor's degree