Clinical Quality and Compliance Supervisor 临床质量与合规主管
主要职责:

1. Conduct commercial site audit to support the screening

2. Cooperate with study team to prepare for regulatory agency audit and other external audit to ensure no critical findings

3. Co-monitor and evaluate CRA/CRO’s performance

4. Review clinical study documents kept by the site(s) and 3rd parties and keep quality control 

5. Support project management with quality control suggestions, and ensure the quality and compliance of clinical studies to meet with IND/NDA requirements 

6. Conduct vendor audit and monitoring

7. Conduct internal audit to assess the compliance

8. Provide training and guidance as needed internally and externally 

9. Prepare and review clinical study documents and keep quality control internally

10. Support the setup of clinical quality system; draft and review SOPs as necessary

任职要求:

 1. Bachelor degree or above in medicine/pharmacology, chemistry, biology, or comparable related experience

 2. At least 2year work experience in clinical study, including auditing/inspecting against regulatory standards and/or work in clinical operation team

 3. Good interpersonal and communication (written and oral) skills

 4. Understanding of regulatory (GCP) requirements

 5. Good English skills (oral and written)

 6. Good team work and problem resolve abilities

招聘人数:1
联系方式:
human_resources@fosunkitebio.com