管理系统专员岗位职责

临床试验管理系统质量控制专员/RegistryQualityControlAssociate辉瑞中国辉瑞投资有限公司,辉瑞,辉瑞中国,辉瑞投资,辉瑞工作职责:

•Upondirection,runandreviewtheRegistryQualityControlreportsorotherlogiccheckmechanismsthroughoutclinicalstudylife.

•Investigatelogiccheckflags,utilizingsysteminformation,aswellasapplicablestudydocumentation.

•ReviewdataattributespopulatedbygeneralusersforadherencetoRegistryDataQualitySpecifications.

•IdentifyandinvestigateanypotentialdiscrepanciesReviewfindingswiththestudyteamPointofContacttoverifydataqualityissues.

•Create,modifyordeletedataattributesintheCTMSsystemaccordingtoRegistryDataEntryspecifications.

•Generaterequiredmetricsforeachstudy.

•FunctionassubjectmatterexpertforRegistrysystemsandtools.

任职资格:

•ExcellentEnglishverbalandwrittencommunicationsskillsandoutstandinglisteningskillsarerequired.

•Historyofachievementinacustomerservicerolewithdemonstrationofmeetingcustomerneedsandconcernsrequired.

•Provenhistoryofleadershiproleswithinateamenvironmentrequired.

•ExperiencewithClinicalTrialManagementSystemspreferred.

•Experienceinmanagementofmedical/clinicalstudyrecordsanddocumentationpreferred.

•Experience/knowledgeofICH/GCPdocumentationrequirementspreferred.

•Metricsmanagementexperience(preferablywithinthefieldofClinicalResearch)preferred.

•Experiencewithwebbaseddatamanagementsystemspreferred.

•Experiencewithdatabaseutilizationpreferred.