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臨床試驗(yàn)管理系統(tǒng)質(zhì)量控制專員

輝瑞(中國)研究開發(fā)有限公司
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工作性質(zhì): 全職 更新日期: 07-27
專業(yè)要求: 不限 學(xué)歷要求: 本科統(tǒng)招
職稱要求: 不限 性別要求: 不限
年齡要求: 不限 經(jīng)驗(yàn)要求: 不限
工作地區(qū): 湖北·武漢 戶口要求: 不限
截止日期: 2025-05-12 外語要求: 不限
工資待遇: 面議 招聘人數(shù): 若干人
其他福利:
免費(fèi)班車 專業(yè)培訓(xùn) 五險(xiǎn)一金 交通補(bǔ)貼 通訊補(bǔ)貼
工作職責(zé):??Upon?direction,?run?and?review?the?Registry?Quality?Control?reports?or?other?logic?check?mechanisms?throughout?clinical?study?life.????Investigate?logic?check?flags,?utilizing?system?information,?as?well?as?applicable?study?documentation.??Review?data?attributes?populated?by?general?users?for?adherence?to?Registry?Data?Quality?Specifications.??Identify?and?investigate?any?potential?discrepancies?Review?findings?with?the?study?team?Point?of?Contact?to?verify?data?quality?issues.??Create,?modify?or?delete?data?attributes?in?the?CTMS?system?according?to?Registry?Data?Entry?specifications.??Generate?required?metrics?for?each?study.??Function?as?subject?matter?expert?for?Registry?systems?and?tools.任職資格:??Excellent?English?verbal?and?written?communications?skills?and?outstanding?listening?skills?are?required.????History?of?achievement?in?a?customer?service?role?with?demonstration?of?meeting?customer?needs?and?concerns?required.??Proven?history?of?leadership?roles?within?a?team?environment?required.??Experience?with?Clinical?Trial?Management?Systems?preferred.??Experience?in?management?of?medical/clinical?study?records?and?documentation?preferred.??Experience/knowledge?of?ICH/GCP?documentation?requirements?preferred.??Metrics?management?experience?(preferably?within?the?field?of?Clinical?Research)?preferred.???Experience?with?web?based?data?management?systems?preferred.???Experience?with?database?utilization?preferred.

On?October?31,?2005,?Pfizer?announced?the?official?opening?of?China?Research?and?Development?Center?(CRDC)?in?Shanghai.?Pfizer?Global?Research?and?Development’s?Center?is?mainly?engaged?in?drug?development?activities.?Much?of?the?facilitys?capacity?is?devoted?to?the?study?design,?data?management?and?statistical?analysis?of?global?phase?I-IV?clinical?trials,?as?well?as?the?clinical?study?report?process.?In?addition,?CRDC?is?a?part?of?Pfizer?global?Safety?and?Risk?Management?and?covers?the?functions?of?safety?data?processing?and?assessment.?The?center?also?trains?Pfizer?employees?in?China?and?throughout?the?Asia?region?in?internationally?recognized?Good?Clinical?Practice?standards.
輝瑞公司于2005年10月31日宣布輝瑞中國研發(fā)中心正式在上海揭幕。輝瑞中國研發(fā)中心主要為全球輝瑞藥物開發(fā)提供支持工作。大部分的功能是圍繞在I-IV期臨床試驗(yàn)研究設(shè)計(jì)、數(shù)據(jù)管理和生物統(tǒng)計(jì)分析、以及臨床試驗(yàn)報(bào)告的部分準(zhǔn)備工作。此外,該中心是輝瑞全球安全和風(fēng)險(xiǎn)管理部的一個(gè)分支,負(fù)責(zé)安全數(shù)據(jù)處理和評(píng)估工作。研發(fā)中心還將為輝瑞公司在中國及亞洲的其它運(yùn)營部門的員工提供國際標(biāo)準(zhǔn)的臨床試驗(yàn)管理規(guī)范(GCP)的技術(shù)培訓(xùn)。
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