2024年临床数据岗位职责(6篇)目录第1篇临床数据分析员岗位职责第2篇临床数据经理岗位职责第3篇临床数据岗位职责第4篇临床数据分析岗位职责第5篇临床数据分析师岗位职责第6篇临床数据助理岗位职责临床数据分析员岗位职责临床数据分析员江苏恩华药业股份有限公司江苏恩华药业股份有限公司,恩华药业,江苏恩华药业,恩华岗位职责:1.负责新药临床研究项目数据的统计与分析工作,收集整理临床诊疗数据并进行挖掘分析;2.参与临床试验方案设计:试验设计、样本量计算、终点指标及其分析方法的选择;3.独立撰写统计分析计划;撰写统计分析报告;4.负责和管理项目进度,以及程序相关的问题沟通;5.其他相关的统计分析。任职要求:1.流行病与卫生统计学、生物统计学、计算机、数学及相关专业,硕士研究生;2.独立完成过临床数据收集、整理、挖掘分析工作;熟悉临床试验设计与统计分析流程,熟练使用sas、stata、spss,prismgraphpad等统计软件和画图软件;3.一年以上大型cro或药厂临床试验sas程序员工作经验者优先。4.cet6,英语听说读写能力良好;5.热爱生物医学数据分析工作,逻辑思维强,具备优秀的团队合作能力和独立解决问题的能力。临床数据经理岗位职责临床数据经理primaryactivitiesinclude,butarenotlimitedto:allresponsibilitiesofaclinicaldatamanager.assumedatamanagementresponsibilitiesforlarger,morecomplexorhigherpriorityprotocols.maycoordinategeneralad-hocsponsordataentry(sde)processfortheprotocol,discusstimelines,andprovidedataentrystatustotheclinicaldevelopmentscientist(cds).provideprotocolspecifictrainingofsdeprocesstocdm.triage,research,discussandresolvethereportsoutputsprovidedbyclinicaldevelopmentscientist(cds)andstatisticiansataprotocollevelduringin-lifeanddatabaselockstagessupportedbythelcdm.supportsthelcdminthepreparation,creationandreviewofdatamanagementtoolspecificationsandtoolsparticipatesinuseracceptancetesting(uat)oftheclinicaldatabaserepositoryunderthedirectionofthelcdm.coordinatescommunications,globalstatustrackingandissueresolutionatstudylevelwithleadcdm(lcdm).responsibleforthecommunicationwithclinicaltrialoperationsteamregardingsitelevelissuesonprotocolabasisonbehalfofthelcdm.monitorprotocollevelcycletimeperformance(metrics)andfollowuponspecificcountries/sitesmetricsissuesanddeliverstatusandresolutionupdatestolcdm.responsibleforstudylevelstatusassessment,reportingandcommunicationwithlcdm.completetriallevelarchivingactivitiesunderthedirectionofthelcdmincluding,butnotlimitedto,filingofessentialdocumentation.coordinateandmentorcdmsandotherscdmswhoworkinhis/herprotocoltoensuretheircompliancewithsops,datamanagementplansanddatareviewplans.beassignedtospecialresponsibilitiesrelatedtoprocessmaintenance,dataqualityassessment,stafftrainingandmentoringand/orotherspecialactivities,suchasprovidinginputstocreateorupdatesops,supportingdocumentsandtrainingmaterialsasneeded.mayberequiredtosupportdmcprocessowner(po)modelsinthelocaldmcand/orintheglobalponetworks.participateincrossfunctionaltechnicalorprocessimprovementprojects.manualencodingleadperformallresponsibilitiesofamanualencoderundertheclinicaldatamanager.ensureencodingaccuracyandconsistencyacrossallprotocolswithinaproject.workscloselywithdmcmanualencodersanddatamanagementtrialmanager(dmtm)toensureallencodingtasksarecompletedpriortointerimanalysis,frozenfiles/databaselocks.servesassubjectmatterexpert(sme)forencodingdocumentsandprocesses.responsibletoreviewspecifiedtherapeuticareaencodingasrequested.coordinateswithlcdmtocreateandreviewencodingspecificationsdocumentsandperformsuseracceptancetesting(uat)ofcodingapplication(s).r...
