职位描述:

1. 在直线经理指导下，完成负责所辖临床项目的方案设计、资料（CRF、研究者手册、综述、总结报告、说明书等）编写；

2. 撰写或更新临床试验相关材料，如伦理会议、启动会等医学相关材料；

3. 在直线经理指导下准备与组织各种临床研究方案研讨活动，与PI和主要研究者定期沟通和联系；

4. 在直线经理指导下，协助解决试验过程中存在的医学问题；

5. 负责所辖临床试验数据的医学审核；

6. 收集临床试验相关文献，撰写新药申报资料的文献综述；

7. 对CRA等研究相关人员的试验方案等培训；

8. 协调公司内部相关人员，解决临床研究和相关工作存在的问题，并作为在研产品的医学专家，培训内部人员并解答存在的问题。

Key Objectives/Deliverables:

1. Under the guidance of the line manager, responsible for the design of clinical programs and the preparation of data (CRF, investigator's brochure, review, summary report, specification, etc.);

2. Write or update clinical trial related materials, such as ethics meetings, initial meetings and other medical related materials;

3. Prepare and organize various clinical research program seminars under the guidance of line manager, communicate and contact with PI and key researchers regularly;

4. Under the guidance of line manager, assist to solve medical problems in the process of testing;

5. Responsible for the medical review of clinical trial data;

6. Collect clinical trial related literature, write literature review of new drug application materials;

7. Training of CRA and other research related personnel on protocol of the trial;

8. Coordinate internal staff to solve problems in clinical research and related work, and train internal staff and answer problems as medical experts in developing products.

任职条件:

岗位要求：

1. 临床医学等相关专业，硕士学历；

2. 至少1年以上相关工作经验 ，有免疫相关领域背景经验更佳；

3. 英语良好，能够熟练阅读英文医学文献，熟练操作办公软件；

4. 有良好的团队合作精神、较好的沟通能力，踏实认真。

Basic Requirements:

1. Master degree or above in clinical medicine or related field;

2. At least 1 year of related working experience, experience in immune related field is preferred;

3. Good Command of English, able to read English medical literature and operate office software;

4. Good team work spirit, good communication skills, practical and serious.