Tasks and Responsibilities:
- Study Execution: Execute assigned BA/BE study as per SOP and applicable regulatory guidelines.
- Document Preparation: Preparation and compilation of essential documents in the Trial Master File, review of CRF and raw data.
- Document Accountability: Responsible for assigned study documents, ensuring adequacy, correctness, and completeness.
- Clinical Updates: Preparation of clinical updates and related communication to bioanalytical and statistics teams.
- Compliance: Provide compliance to QC and QA observations.
- Informed Consent: Perform informed consent presentations and obtain consent during screening and study phases.
- Screening Activities: Perform registration and screening-related activities.
- SOP Management: Preparation and review of SOPs, and responsible for training staff as needed.
- Pharmacy Activities: Perform pharmacy-related activities as required.
- Other Duties: Perform any other activities delegated by Head CR/PI/Manager Operation.
Interested Candidates:
Share your CV at careers@synergenbio.com
