DOX JD-pfizer-临床数据管理员

Ms.EchoMA,Consultant,DOXexecutivesearchingfirmMr.RyanChen,SeniorConsultant,DOXexecutivesearchingfirmDOXInc.–Aleadingexecutivesearchingfirmdedicatedfortop20leadingmultinationalpharmaceuticalcompaniesworldwideinGreaterChinaregion.ShanghaiBranch:Suite1603,Floor16,CityGateway,398CaoxiNorthRoad,XuhuiDistrict,Shanghai,200030,ChinaOfficeTel:[phone];33632769MobilPhone:[phone];15821905516Email:[e-mail];[e-mail]iledresumebothinEnglishandChinesetous,andourconsultantwillcontactyousoontolearnyourexperienceandexpectation,andalsobriefthepositionindetailsforyou.请准备您的详细中英文资料(含报名照)给我,以便稍后面谈我们作为该客户下列特定职位在现阶段的独家委托招聘服务提供商，将为您提供职业发展规划，工作机会分析，客户推荐，面试安排和录用通知书签订，上岗工作到试用期通过的全部猎头咨询服务，在此期间您的个人信息和求职意向会得到我们和客户公司的高度保密，请按照上面联系方式直接联系我们的咨询顾问。Recruitingcompanyandpositionbrieftocandidates招聘公司&职位简介辉瑞武汉研发中心PositionDataManager(CDS)LocationWuhanPositionPurposeTheDataManagerisresponsibleforensuringthecompleteness,qualityandintegrityofthesubjectdatastoredwithintheclinicaltrialdatabase.TheDataManagerisresponsiblefordatacleaningaspectsofthedatamanagementrolewithinaclinicaltrial,accordingtoPfizerStandards,ProcessesandStandardOperatingProcedures(SOPs).TheDataManagerworkswiththeglobalstudyteamtomeetthestudyobjectivesinthereleaseofdatabases.TheDataManagerwillensuretheconsistentuseandapplicationofstandards.Theultimateobjectiveistoensuredataqualityandconsistencyacrossprogramsandrepositories.OrganizationalRelationships:DirectlyreportingrelationshiptoDMTALeadorTeamLeadinCDSStrongpartnershipswithLeadDataManagers(LDM),ProjectDataManagementLeads(PDL),andDataBaseManagers(DBM)withinPfizerPartnershipwithotherrelatedfunctionsinstudyteamsasneeded.PrimaryDuties:GeneralEnsurethatalldatacomponentsareconductedincompliancewithGCP,relevantSOPs,andregulatoryrequirements.EnsuresConformancetoPfizerDataStandardsordesignateddatastandards.Activelyparticipatesinmonthlyprojectreviewmeetings.Specific:CreatetheDataManagementPlan(DMP)forcompletenessandaccuracy,includingtheDataFlowActivitiesDocument,CRFCompletionGuidelines,DataQualitySpecification(Editchecks),DataListingDocuments,DataHandlingConventions(PermissibleChanges),DataQualityControlPlanandDataEntryGuidelines.Set-upandtestdatareviewlistingstoverifythequalityandcompletenessofdataasspecifiedintheDataQualitySpecification(Editchecks)document.Ensuretimelyset-upofclinicaldataacquisitionandmanagementtoolsanddatavalidation.MaintainaStudyTrackingSpreadsheettotracktheprogressofCRFretrieval,dataentryofCRFsanddatacleaningactivities.Performdatacleaningactivitiesincludingdiscrepancymanagement(reviewoferrorsfromelectronicchecks)andreviewofdatalistingstoverifyqualityandcompletenessofdataandissueDataClarificationForms(DCFs)asnecessarytoseekfurtherclarificationfromsites.EnsureintegrityofclinicaldataandupdatedatabasewithresolvedDCFsasnecessary.ReconciletheSeriousAdverseEvent(SAE)databetweenpatientdatabaseandthesafetydatabase.Documentalleffortsinthecleaningandreleaseofthedatabase.EnsurefilingofallclinicaltrialdocumentationtotheTrialMasterFile.Training&EducationPreferred:Bachelor’sdegreeorequivalentinanatural/medicalscience,datamanagementorrelateddiscipline.FluentEnglishbothinreadingandwritingPriorExperiencePreferredWorkingknowledgeofclinicaldevelopmentprocess,understandingconceptsofPhaseI-IVandprinciplesofstudydesign.Previousexperiencewithinadatamanagementrole,understandingkeyprocessesandprinciplesassociatedwithroleincludingCRFdesign,databaseset-up,editcheckspecification,DMPanddatacleaningactivities.KnowledgeofWindowsEnvironmentanditsapplications(Word,ExcelandPowerPoint,Project,etc.).TechnicalCompetenciesCompetencyDetail/Comments(specificskills,etc.)DatamanagementexperienceDemonstratedknowledgeofclinicaldevelopmentprocessincludingknowledgeandunderstandingoftheprinciplesofGCPDemonstratedknowledgeofdatamanagementprocessesandprinciplesinareaofresponsibility.OrganizationalskillsWorksindependently,receivesinstructionprimarilyonunusualsituationsAbilitytoorganizetasks,timeandpriorities;abilitytomulti-taskCommunicationskillsAbilitytocommunicateeffectivelyandappropriatelywithinternal&externalstakeholders,locallyandgloballyProblemsolvingAbilitytoworkinambiguoussituationswithinteamstoidentifyandarticulatecomplexproblemsClinical®ulatoryprocessesDemonstratedknowledgeofclinicaldevelopmentandregulatorysubmissionprocessesandrequirements.SystemstechnologiesKnowledge/proficiency/understandingoftechnologiestosupportdataacquisition,computerizationanddatavalidation,computersystemslifecycletechnologyStrongunderstandingofthestate-of-the-arttechnologiestoevaluateandleveragethemintoimprovedbusinessprocessesforworldwidedeploymentandadoption.