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