職位描述
職稱：助理臨床數(shù)據(jù)管理專員(臨床試驗(yàn)）
單位：亞太區(qū)臨床數(shù)據(jù)管理中心
工作地點(diǎn)：北京
工作職責(zé)：
臨床報(bào)告數(shù)據(jù)管理工作是臨床研究的一個(gè)重要組成部分。助理臨床數(shù)據(jù)管理專員負(fù)責(zé)確保默克公司研究或銷售產(chǎn)品的所有臨床試驗(yàn)數(shù)據(jù)的完整性，準(zhǔn)確性和一致性。在公司內(nèi)部方針允許的時(shí)間范圍內(nèi)，利用一系列計(jì)算機(jī)程序和數(shù)據(jù)庫系統(tǒng)來支持受試者數(shù)據(jù)的收集，整理和管理。此外，還需要與公司不同部門和全球客戶進(jìn)行有效溝通以及緊密合作。
主要活動(dòng)包括但不限于：
?數(shù)據(jù)管理工作, 包括在一定時(shí)間內(nèi)收集，整理和核查(邏輯核查及醫(yī)學(xué)核查)臨床試驗(yàn)數(shù)據(jù)。
?確保臨床試驗(yàn)數(shù)據(jù)的完整性，準(zhǔn)確性和內(nèi)部數(shù)據(jù)庫的一致性，使其符合報(bào)告至管理機(jī)構(gòu)的質(zhì)量標(biāo)準(zhǔn)。
?與臨床實(shí)驗(yàn)的各國臨床監(jiān)察員和研究者就臨床報(bào)告管理工作進(jìn)行密切溝通及協(xié)調(diào)。
?就臨床數(shù)據(jù)問題與項(xiàng)目主管進(jìn)行溝通。
?對(duì)新員工進(jìn)行培訓(xùn)和指導(dǎo)，并提供支持和幫助。
要求：
?教育：醫(yī)學(xué)及生命科學(xué)相關(guān)專業(yè)本科以上學(xué)歷, 醫(yī)學(xué)，藥學(xué)，護(hù)理，公衛(wèi), 醫(yī)學(xué)英語專業(yè)優(yōu)先考慮
?知識(shí)與技能:
o良好的自我激勵(lì)，任務(wù)管理和時(shí)間管理。
o優(yōu)秀的英語口語和寫作能力。
o擅長獨(dú)立分析問題和解決問題。
o優(yōu)秀的組織，溝通和數(shù)據(jù)管理技能（注重細(xì)節(jié)）
o能承受工作壓力，具有團(tuán)隊(duì)合作精神，強(qiáng)烈的責(zé)任感和問責(zé)意識(shí)
Job title: Associate Data Coordinator (Clinical Trial)
Department: Global Data Management & Standards (GDMS) China Data Management Center (DMC)
Job Location: Beijing
Responsibilities:
The Associate Data Coordinator (Clinical Trial) is responsible for ensuring the completeness, accuracy and consistency of all clinical trial data for investigative or Merck marketed products using a range of computer applications and database systems to support collection, cleaning and management of subject or patient data, and is processed within a time frame that permits compliance within internal guidelines. In addition, interacts effectively and works closely with people across functional areas within the organization and global customers.
Primary activities include, but are not limited to:
? Collect, clarify and review clinical trial data within the timeframe
? Ensure completeness, accuracy and consistency of the clinical data in the internal database so that it meets the standards of quality expected for reporting to regulatory bodies
? Communicate with Data Project Lead for clinical data inquiry and data issues
? Provide training/ mentoring for new coordinators and serves as a resource for less experienced coordinator
Requirement:
? Education: At least B.A. or B.S. degree in Medicine or Life Sciences, preferably in Clinical Medicine, Pharmacy, Nursing, Public Health or related discipline
? Knowledge and Skills:
? Self motivated, excellent in assignments priority and time management.
? Excellent oral and written English skills.
? Independent, strong analytical and problem solving skills
? Excellent organizational, communication, and data management skills (detail orientated)
? Able to work under the pressure, team player, strong sense of responsibility and accountability.
