Sr Clinical Research Manager

工作职责：You will be responsible to set up Action Plan and conduct clinical studies for product registration purpose in a timely manner and with the most cost efficient manner and to establish and maintain the good and closed relationship with lab chiefs. Builds up and represents Roche Diagnostics' good image. 依据公司产品注册计划，制定临床试验计划及时高效完成临床试验; 建立并保持与研究者的良好关系，树立公司形象。 - Leading a team, working across-functional to complete clinical studies for product registration purpose. Achieving RD expectation on product registration. 带领团队,跨部门合作完成产品注册临床试验;达到公司对产品注册的要求 - Setting up clinical trail SOP and updating SOP in time, improving working efficiency; 制定临床工作SOP，并及时更新，提高工作效率 - Evaluating and determining clinical protocol and clinical report; 评估并决定临床实验方案及临床实验报告 vEstablishing and maintaining the good relationship with key opinion leaders. Recommending valuable suggestion to company; 建立并保持与研究者的良好关系,为公司提供有价值的意见 - As a member of RD, providing active and strong technical supports to internal dept. as needed; 作为团队的一分子,积极为各部门和内部员工提供及时和有力的技术支持 - Ensuring the compliance of Good Clinical Practice and other regulations. 符合GCP操作规范

任职资格：At least Bachelor degree in Science Degree preferably in Health Sciences like Clinical Diagnostics or engineering; 本科学历理科专业，健康科学（临床诊断或工程类）尤佳 vProficiency in both spoken and written English and good command of MS office software application; 熟练掌握英语口语及书面表达, 熟练应用微软办公软件 - Understand medical device regulation. 了解医疗器械法规 You should have at least 5 years of working experience in either a Medical Device or Diagnostics industry, and 2 years of working experience in clinical study of IVD/Medical Device/Drug. 医疗器械或体外诊断行业至少5年经验, 两年以上体外诊断/医疗器械/药品临川试验经验