崗位職責:
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.負責實施對應項目組相關的醫(yī)學支持工作:國內(nèi)外相關藥物的跟蹤查閱、臨床試驗方案、總結報告等的撰寫、其他成員的臨床方案培訓、臨床試驗的醫(yī)學審核和醫(yī)學質量保證
2.根據(jù)臨床項目的需求,在上級指導下與臨床醫(yī)學專家、CDE審評專家和其他臨床研究資源進行臨床方案設計相關的溝通。
任職要求:
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.
博士學歷,3年及以上腫瘤醫(yī)學工作經(jīng)驗、參與過2個以上大臨床項目的醫(yī)學方案制定、熟悉醫(yī)學專業(yè)相關知識;掌握藥物臨床開發(fā)相關的業(yè)務流程和法規(guī)要求、熟悉GCP、能夠獨立撰寫仿制藥臨床試驗方案、總結報告;對內(nèi)對外溝通能力良好。