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临床数据经理岗位职责
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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,creationandreviewofdatamanagementtoolspecificationsandtools
?ParticipatesinUserAcceptanceTesting(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.
ManualEncodingLead
?PerformallresponsibilitiesofaManualEncoderundertheClinicalDataManager.
?Ensureencodingaccuracyandconsistencyacrossallprotocolswithinaproject.
?WorkscloselywithDMCmanualencodersandDataManagementTrialManager(DMTM)toensureallencodingtasksarecompletedpriortointerimanalysis,frozenfiles/databaselocks.
?ServesasSubjectMatterExpert(SME)forencodingdocumentsandprocesses.
?Responsibletoreviewspecifiedtherapeuticareaencodingasrequested.
?CoordinateswithLCDMtocreateandreviewencodingspecificationsdocumentsandperformsUserAcceptanceTesting(UAT)ofcodingapplication(s).
?ResponsibleforencodingexternalpartnerdataasapplicableandconsultantforContractResearchOrganization(CRO)partners.
?Runsencodingcheckreportsinaccordancewithdatareviewplanstoidentifyencodingissues.
?RaisesquestionswithinvestigationalsitestafforDMCmanualencodersandreviewsresponsesandcorrespondingdatacorrectionstoconfirmresolution.
?Responsibleforstudylevelencodingstatusreportingandassessment,andcommunicationwithDMCClinicalTrial(CT)managementduringin-lifedatamanagementactivitiesandpreparationfordatabaselock.
Requirements
Education:
1.AtleastB.A.orB.S.degree,preferablyinMedicine,Pharmacy,Nursing,BiologicalSciences,orhealthcarerelateddiscipline.
KnowledgeandSkills:
1.Twoyears’experienceinclinicaldatamanagementinpharmaceuticalorhealthcareclinicalresearchenvironmentispreferable.
2.Self-motivated,excellentinworkplanningandtimemanagement.
3.FluentoralandwrittenEnglishskills.
4.Goodbasicawarenessoftheclinicaldevelopmentprocess.
5.Goodbasicawarenessofclinicalpracticeandgraspofmedicalterminology.
6.Goodsenseandawarenessofregulationsandpolicies.
7.Abletoworkunderpressureandinachangingenvironmentwithflexibility.
8.Goodcommunicationskillswiththeabilitytocommunicatewithbothtechnicalandbusinessareas.
9.Provenleadershipskills,specificallytheabilitytocoordinatetheworkofothersandinfluencemanagementondecisionmaking.Primaryactivitiesinclude,butarenotlimitedto:
?AllresponsibilitiesofaClinicalDataManager.
?Assumedatamanagementresponsibilitiesforlarger,morecomplexorhigherpriorityprotocols.
?Maycoordinategeneralad-hocSponsorDataEntry(SDE)processfortheprotocol,discusstimelines,andprovidedataentrystatustotheClinicalDevelopmentScientist(CDS).
?ProvideprotocolspecifictrainingofSDEProcesstoCDM.
?Triage,research,discussandresolvethereportsoutputsprovidedbyClinicalDevelopmentScientist(CDS)andStatisticiansataprotocollevelduringin-lifeanddatabaselockstagessupportedbytheLCDM.
?SupportstheLCDMinthepreparation,creationandreviewofdatamanagementtoolspecificationsandtools
?ParticipatesinUserAcceptanceTesting(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.
ManualEncodingLead
?PerformallresponsibilitiesofaManualEncoderundertheClinicalDataManager.
?Ensureencodingaccuracyandconsistencyacrossallprotocolswithinaproject.
?WorkscloselywithDMCmanualencodersandDataManagementTrialManager(DMTM)toensureallencodingtasksarecompletedpriortointerimanalysis,frozenfiles/databaselocks.
?ServesasSubjectMatterExpert(SME)forencodingdocumentsandprocesses.
?Responsibletoreviewspecifiedtherapeuticareaencodingasrequested.
?CoordinateswithLCDMtocreateandreviewencodingspecificationsdocumentsandperformsUserAcceptanceTesting(UAT)ofcodingapplication(s).
?ResponsibleforencodingexternalpartnerdataasapplicableandconsultantforContractResearchOrganization(CRO)partners.
?Runsencodingcheckreportsinaccordancewithdatareviewplanstoidentifyencodingissues.
?RaisesquestionswithinvestigationalsitestafforDMCmanualencodersandreviewsresponsesandcorrespondingdatacorrectionstoconfirmresolution.
?Responsibleforstudylevelencodingstatusreportingandassessment,andcommunicationwithDMCClinicalTrial(CT)managementduringin-lifedatamanagementactivitiesandpreparationfordatabaselock.
Requirements
Education:
1.AtleastB.A.orB.S.degree,preferablyinMedicine,Pharmacy,Nursing,BiologicalSciences,orhealthcarerelateddiscipline.
KnowledgeandSkills:
1.Twoyears’experienceinclinicaldatamanagementinpharmaceuticalorhealthcareclinicalresearchenvironmentispreferable.
2.Self-motivated,excellentinworkplanningandtimemanagement.
3.FluentoralandwrittenEnglishskills.
4.Goodbasicawarenessoftheclinicaldevelopmentprocess.
5.Goodbasicawarenessofclinicalpracticeandgraspofmedicalterminology.
6.Goodsenseandawarenessofregulationsandpolicies.
7.Abletoworkunderpressureandinachangingenvironmentwithflexibility.
8.Goodcommunicationskillswiththeabilitytocommunicatewithbothtechnicalandbusinessareas.
9.Provenleadershipskills,specificallytheabilitytocoordinatetheworkofothersandinfluencemanagementondecisionmaking.
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