工作职责: 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. 任职资格: 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 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.