Clinical Quality & Compliance Manager 临床质量与合规经理
主要职责:
      

1. To set up clinical SOPs based on GCP  

2. To renew the clinical SOPs as needed  

3. To review and quality control SOPs of 3rd parties, from trial initiation to completion

4. To help generate and review clinical study documents and keep quality control internally  

5. To review clinical study documents of 3rd parties and keep quality control  

6. To give training and guidance as needed internally and externally

7. To support project management with quality control suggestions  

8. To co-monitor and evaluate CRA/CRO’s performance  

9. To cooperate with study team to prepare for audit and ensure no critical findings with CAPA timely for each audit

10. To ensure the quality and compliance of clinical studies to meet with IND/NDA requirements        

11. To support other related work as company/department needed

任职要求:

1. Bachelor degree or above, medicine/pharmacology/biology is preferred

2. At least 3 years clinical research experience, oncology/haematology area is preferred

3. At least 1 year quality control and familiar with the compliance requirement in clinical trial is preferred.

4. With experience of clinical operation SOP writing is preferred.

5. With excellent communication skills

6. With ICH-GCP/GCP training

7. With good English skills (oral and writing)

8. With team work and problem resolve abilities


招聘人数:1