职位描述

岗位职责: As a Senior Medical Manager, the individual will be assist with the development and execution of medical monitor strategy and plan to provide medical monitoring in accordance with the internal and external priorities and requirements, and in strict adherence to the company s corporate policies, guidelines and requirements. MAIN RESPONSIBILITIES •To provide overall medical and safety oversight of clinical trials as assigned. •To contribute the clinical study extended synopsis based on feasibility pre-assessment, protocol complexity index and associated cost with professional medical and study-specific knowledge. •To interact with inter-departmental and external consultants, investigators, and regulatory agencies as appropriate. •To assist with supervising the medical and safety monitoring activities, including but not limited to clinical lab values, AEs, coding dictionaries and data tables, listings and figures. •To insure medical answers to the questions from Health Authorities, IRB/Ethics Committees, Investigators, experts, clinical study team timely and appropriately. •To review/approve medical-related documents (e.g. specifications for centralized services, Protocol, ICF, CRF, CRF completion guidance, patient diary, etc.). •To provide project-specific and therapeutic training to sponsors and company staff as needed. •To assist with maintaining the in-depth knowledge of CFDA and worldwide drug-development regulations, national and ICH Good Clinical Practice (GCP) guidelines. 任职要求: •Master Degree or above in clinical medicine, Ph.D. or M.D. is a plus •Around 3 years’ work experience and 1 years of medical monitoring •Fluent verbal and written English (equals to CEF C1, BEC H, IELTS 7.0,CET-6) •Ability to work independently and handle multiple tasks simultaneously under pressure •行业经验:至少2年医生经验外加至少3年甲/乙方企业经验 •岗位经验:如果有眼科项目或眼科医生经验优先 •Good communication skills and good team player •Ability to coach other medical monitors •Global, cross-cultural perspective and customer orientation LOCATION •Beijing, Shanghai (Tianjin, Guangzhou, Wuhan, Chengdu can also be considered) or(远程办公)

其他要求

招聘人数: 999
职能类别:

公司介绍

康德弘翼(WuXi Clinical),是药明康德(WuXi AppTec)的一家全资子公司。始终致力为全球客户提供全方位的临床研究服务,包括药品、生物制品、医疗器械、体外诊断试剂等医药产品,涵盖BE (Bioequivalence) / I期至IV期的临床试验。通过严格的质量控制体系和专业团队的丰富经验,帮助创新性,突破性医药产品尽快上市和造福患者。康德弘翼立足中国,面向世界,以上海总部为中心,辐射全球制药公司、生物技术公司以及医疗器械公司。目前,公司实行全球联合运营,人员规模达850+人,运营能力覆盖中国、美国及澳大利亚等,并在上海、北京、广州、武汉、成都、长沙、西安、沈阳、中国台北、美国奥斯汀、美国圣地亚哥和澳大利亚悉尼等地均设有办公室。公司团队与各研究中心建立了良好的合作关系,始终保持着紧密的业务交流,保证了项目能高效、高质地完成。随着业务能力和业务范围的不断拓展,康德弘翼进一步完善和增强了全球一体化研发服务平台的综合实力,助力全球创新合作伙伴更好、更快地开发医药产品。

企业信息

  • 名称:上海康德弘翼医学临床研究有限公司
  • 行业:制药.生物
  • 性质: 其他
  • 规模: 100-499人

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