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更新于 12月9日

(Sr.)醫(yī)學(xué)經(jīng)理

3-4萬
  • 北京朝陽區(qū)
  • 5-10年
  • 碩士
  • 全職
  • 招999人

職位描述

眼科Ⅲ期Ⅱ期上市前臨床醫(yī)學(xué)
崗位職責(zé):
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.
任職要求:
?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
?行業(yè)經(jīng)驗(yàn):至少2年醫(yī)生經(jīng)驗(yàn)外加至少3年甲/乙方企業(yè)經(jīng)驗(yàn)
?崗位經(jīng)驗(yàn):如果有眼科項(xiàng)目或眼科醫(yī)生經(jīng)驗(yàn)優(yōu)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(遠(yuǎn)程辦公)

工作地點(diǎn)

北京朝陽區(qū)兆泰國際中心C座8層

職位發(fā)布者

顧意蓉/高級人力資源專員

立即溝通
公司Logo上??档潞胍磲t(yī)學(xué)臨床研究有限公司
康德弘翼(WuXi Clinical)始終致力為全球客戶提供全方位的臨床研究服務(wù),包括藥品、生物制品、醫(yī)療器械、體外診斷試劑等醫(yī)藥產(chǎn)品,涵蓋BE(Bioequivalence)/ I期至IV期的臨床試驗(yàn)。通過嚴(yán)格的質(zhì)量控制體系和專業(yè)團(tuán)隊(duì)的豐富經(jīng)驗(yàn),幫助創(chuàng)新性,突破性醫(yī)藥產(chǎn)品盡快上市和造?;颊摺?档潞胍砹⒆阒袊嫦蚴澜?,以上海總部為中心,輻射全球制藥公司、生物技術(shù)公司以及醫(yī)療器械公司。目前,公司實(shí)行全球聯(lián)合運(yùn)營,人員規(guī)模達(dá)850+人,運(yùn)營能力覆蓋中國、美國及澳大利亞等,并在上海、北京、廣州、武漢、成都、長沙、西安、沈陽、中國臺北、美國奧斯汀、美國圣地亞哥和澳大利亞悉尼等地均設(shè)有辦公室。公司團(tuán)隊(duì)與各研究中心建立了良好的合作關(guān)系,始終保持著緊密的業(yè)務(wù)交流,保證了項(xiàng)目能高效、高質(zhì)地完成。隨著業(yè)務(wù)能力和業(yè)務(wù)范圍的不斷拓展,康德弘翼進(jìn)一步完善和增強(qiáng)了全球一體化研發(fā)服務(wù)平臺的綜合實(shí)力,助力全球創(chuàng)新合作伙伴更好、更快地開發(fā)醫(yī)藥產(chǎn)品。
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