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更新于 8月13日
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南京-臨床數(shù)據(jù)管理員

8000-11000元
  • 南京江寧區(qū)
  • 1-3年
  • 本科
  • 全職
  • 招1人

職位描述

臨床數(shù)據(jù)分析
Responsibilities:
  1. CRF/DCF tracking;
  2. Develop test scripts and execution logs for User Acceptance Testing (UAT);
  3. Database audit;
  4. Perform data review;
  5. Create and maintain Data Management Plan under the supervision of senior members;
  6. Create and maintain Data Validation Plan under the supervision of senior members;
  7. Create and maintain Data Entry Guidelines;
  8. Create Data Handling Plan under the supervision of senior members;
  9. Create Data Transfer Specification under the supervision of senior members;
  10. Perform CRF design and CRF review under the supervision of senior members;
  11. Develop database (DB) clinical trial data specifications under the supervision of senior members, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
  12. Perform SAE reconciliation;
  13. Perform external data reconciliation in collaboration with programmers;
  14. Other DM tasks as deemed appropriate by senior members.
  15. Other activities/tasks assigned by supervisor.
Qualification:
  1. Bachelor’s degree in clinical/pharmacy/biological/mathematical sciences or related field or nursing degree with 1-3 year clinical experience.
  2. Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  3. Good understanding of clinical drug development process.

工作地點(diǎn)

南京江寧區(qū)南岸·瑞智99文化創(chuàng)意產(chǎn)業(yè)園

職位發(fā)布者

劉女士/TAM

昨日活躍
立即溝通
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昆翎（ClinChoice）是一家致力于為生物醫(yī)藥和醫(yī)療器械客戶(hù)提供高品質(zhì)一站式服務(wù)的臨床階段CRO，服務(wù)包括臨床運(yùn)營(yíng)、項(xiàng)目管理、生物統(tǒng)計(jì)、數(shù)據(jù)管理、注冊(cè)事務(wù)、醫(yī)學(xué)事務(wù)和藥物警戒。昆翎已經(jīng)在中國(guó)、美國(guó)、歐洲、印度、日本和菲律賓建立了主要的臨床交付中心，目前在全球擁有1800多名員工，其臨床運(yùn)營(yíng)團(tuán)隊(duì)覆蓋了亞、歐、北美等七個(gè)國(guó)家和地區(qū)。高盛直投部董事總經(jīng)理、昆翎董事會(huì)成員許小鷗先生認(rèn)為，“隨著創(chuàng)新療法在全球的增長(zhǎng)，CRO公司提供高效、可靠的研發(fā)服務(wù)能力變得尤其重要。昆翎獨(dú)特的價(jià)值主張結(jié)合了其對(duì)于本地市場(chǎng)的了解、國(guó)際藥物研發(fā)的經(jīng)驗(yàn)以及高效的團(tuán)隊(duì)執(zhí)行能力。我們堅(jiān)信公司強(qiáng)勁的管理層團(tuán)隊(duì)以及其高效的執(zhí)行能力，將為昆翎的發(fā)展開(kāi)啟新的篇章。
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