上海招聘

1.To ensure all the related clinical research operations and procedures are in compliance with protocol, Ferring’s SOPs, ICH-GCP/Chinese GCP and applicable local regulations.

2. To be responsible for clinical study sites selection and to ensure these sites are meet the Ferring’s requirement and qualified with SFDA.

3. To be responsible for EC submission and contract negotiation.

4. To be responsible for initiating, monitoring and closing the clinical study site and submit the monitoring report on time.

5. To be responsible for arranging and preparing Investigator Meeting.

6. To ensure the study sites storage, distribution, return IMP/NIMP and report of deviations in compliance with protocol, Ferring’s SOPs, ICH-GCP/Chinese GCP and applicable local regulations.

7. To be responsible for using CTMS in clinical trial and ensure that information entered into CTMS is accurate and update on a regular basis.

8. To ensure the study sites report appropriately all AEs according to timeline stipulated in clinical study protocols.

9. To ensure the study sites update and maintain essential documents in Investigator Files on time.

10. To ensure essential documents transferred to TMF are consist with IF

11. To ensure transfer the trial related documents to CTA on time.

12. Ensure the quality of the data.

13. To build and keep good working relationship with the clinical study sites.

14. Assist Clinical Trial Manager management the clinical trial

15. To be responsible for planning, organizing, implementing the co-monitoring and report to Clinical Operation Manager.

16. As a core team member in internal training group, is responsible for planning, organizing, implementing the team training and responsible for improving the monitors' performance.

Job Requirements:

1. Bachelor degree or above in Medical, Pharmacy or related areas.

2. With at least 3 year experience in Clinical Research and Monitoring.

3. Be familiar with ICH-GCP/Chinese GCP and applicable local regulations.

4. With a reliable, responsible, diligent and positive working attitude.

5. Expect to work under strong pressure and to travel frequently.

6. Excellent in communication skills and is expected to establish good relationship with the Investigators and other related site personnel.

7. Self-motivated for success

8. Good professional image.

9. Effective operation both independently and as a team member. Role related Performance Indicators

瑞石生物医药有限公司于2018年1月创立，总部位于中国上海，在北京及美国波士顿设有分支机构，是一家创新的研发驱动型全球生物制药公司，立足于开发临床急需的创新药物以满足患者的需求。目前，瑞石专注于自身免疫类疾病创新药物的全球开发，一方面与国内领先的制药企业恒瑞合作将中国创新药物引入美国及欧洲，助力中国创新走向世界；另一方面还借助公司管理团队在中国开展创新药物研发的丰富经验，积极引进国际领先的创新药物解决中国患者的临床需求。