工作职责:
ROLESUMMARY
AspartoftheDataMonitoringandManagementgroup,anintegraldeliveryunitwithintheGlobalBiometricsandDataManagement(GBDM)organization,theDataManagerisresponsiblefortimelyandhighqualitydatareviewandquerymanagementofclinicaldatasupportingthePfizerportfolio. TheDataManagerdevelopsandmaintains keydatamanagementdeliverablesusedtocollect,review,monitor,andensuretheintegrityofclinicaldata.
ROLERESPONSIBILITIES
ServeasLeadDataManagerforoneormoreclinicaltrialsassumingresponsibilityforDMMactivitiesincludingselectionandapplicationofdataacquisitionstandards,databasedesign(includingspecificationdocumentationandtestingofclinicaldatacollectiontools,bothCRFandnon-CRF,usinganEDCsystemand/orotherdatacollectionsystems),developmentandmaintenanceoftheDataManagementPlan,datareviewandquerymanagement,dataaccessandvisualization,DataManagementmetricsreporting,databaserelease,andsubmissionrelatedactivities.
IndependentlyleadthedailyDMactivitiesandallocatestudyDMresourceintheappropriateway.
CoachjuniorDataManagersinthestudyandperformpeerreviewofstudyDM
sdeliverablesforqualitycontrol.
BeresponsibletoachievethestudyDMmilestoneontimewithgoodquality.
IncollaborationwiththeClinicalDataScientist,ensureoperationalexcellenceacrossallDMMdeliverables.
EnsureworkcarriedoutinaccordancewithapplicableSOPsandworkingpractices.
Ensuretherequiredstudy-specificDMMdocumentsintheTrialMasterFile(TMF)areofhighqualityandarefiledcontemporaneouslytosupportdownstreaminspectionandsubmissionreadinessactivities.
EnsureoperationalexcellenceincollaborationwithCDSforapplicationofstandards,dataacquisition,proactivedatareviewandquerymanagement,datacleaning,e-dataprocessing,dataaccessandvisualization,DMmetricsreporting,databaserelease,andsubmissionrelatedactivities.
Ensurelessonslearntduringthecourseofthestudyaredocumentedandsharedwithotherstudyteamstofacilitatecrossstudylearning.
BecapabletocontributeontheDMrelatedcontinuousimprovementactivities
QUALIFICATIONS
DemonstratedknowledgeofclinicaldevelopmentprocessincludingknowledgeandunderstandingoftheprinciplesofGCP
Demonstratedknowledgeofdatamanagementprocessesandprinciplesinareaofresponsibility.
Workingknowledgeofallphasesofclinicaltrialsandabilitytoassessanddeterminestudyrequirementfromprotocolreview
Demonstratesstrongverbalandwrittencommunicationskillsincludingabilitytocommunicateremotely
Minimum3yearsDataManagementexperiencerequired
Workingknowledgeofclinicalresearch,FDA&ICH,GCP,GCDMP,andrelatedregulatoryrequirements
Proficientexperienceusingcommercialclinicaldatamanagementsystemsand/orEDCproducts(e.g. ,Informpreferred)
Experienceusingdatavisualizationtools(e.g.Spotfire, J-Review)preferred
FamiliaritywithMedDRA/WHO-Drug
ProficiencyintheuseofMicrosoftOfficeSuiteoftools(Outlook,Word,Excel,etc.)
Bachelor’sdegreeminimumrequirement.
Experienceofprojectmanagementskillintermsofresourcemanagementandtimelineandqualitycontrolpreferred.
任职资格:
QUALIFICATIONS
DemonstratedknowledgeofclinicaldevelopmentprocessincludingknowledgeandunderstandingoftheprinciplesofGCP
Demonstratedknowledgeofdatamanagementprocessesandprinciplesinareaofresponsibility.
Workingknowledgeofallphasesofclinicaltrialsandabilitytoassessanddeterminestudyrequirementfromprotocolreview
Demonstratesstrongverbalandwrittencommunicationskillsincludingabilitytocommunicateremotely
Minimum3yearsDataManagementexperiencerequired
Workingknowledgeofclinicalresearch,FDA&ICH,GCP,GCDMP,andrelatedregulatoryrequirements
Proficientexperienceusingcommercialclinicaldatamanagementsystemsand/orEDCproducts(e.g. ,Informpreferred)
Experienceusingdatavisualizationtools(e.g.Spotfire, J-Review)preferred
FamiliaritywithMedDRA/WHO-Drug
ProficiencyintheuseofMicrosoftOfficeSuiteoftools(Outlook,Word,Excel,etc.)
Bachelor’sdegreeminimumrequirement.
Experienceofprojectmanagementskillintermsofresourcemanagementandtimelineandqualitycontrolpreferred.
