岗位职责:

1. Be responsible for implementing the relevant medical support work of the corresponding project team: tracking and consulting relevant domestic and foreign drugs, writing clinical trial protocols, summary reports, etc., conducting clinical protocol training for other team members, and performing medical review and ensuring medical quality in clinical trials.

2. According to the requirements of clinical projects, under the guidance of superiors, communicate with clinical medicine experts, CDE review experts and other clinical research resources regarding the design of clinical protocols.

1.负责实施对应项目组相关的医学支持工作：国内外相关药物的跟踪查阅、临床试验方案、总结报告等的撰写、其他成员的临床方案培训、临床试验的医学审核和医学质量保证

2.根据临床项目的需求，在上级指导下与临床医学专家、CDE审评专家和其他临床研究资源进行临床方案设计相关的沟通。

任职要求:

Have three years or more working experience in oncology medicine, participated in the formulation of medical protocols for more than two large clinical projects, be familiar with relevant knowledge of medical specialty; master the business processes and regulatory requirements related to drug clinical development, be familiar with GCP, be able to independently write clinical trial protocols and summary reports for generic drugs; possess good communication skills both internally and externally.

博士学历，3年及以上肿瘤医学工作经验、参与过2个以上大临床项目的医学方案制定、熟悉医学专业相关知识；掌握药物临床开发相关的业务流程和法规要求、熟悉GCP、能够独立撰写仿制药临床试验方案、总结报告；对内对外沟通能力良好。