高级临床监查员 I/II（外派外资药厂）

岗位职责

职责要求：• Drivestudyperformanceatthesites.Performsitemonitoringandotheronsitevisitactivitiesaccordingtomonitoringplanandincompliancewithproceduraldocuments.Providetherequiredmonitoringvisitreportswithinrequiredtimelines.Proactivelyidentifystudy-relatedissuesandescalatestoLocalStudyTeamasappropriate.• Contributetotheselectionofpotentialsitesandinvestigators.Train,supportandadviseInvestigatorsandsitestaffinstudyrelatedmatters.• ObtainandmaintainessentialdocumentationincompliancewithICH-GCP,ProceduralDocumentsandlocalregulations.Managestudysupplies(ISF,CRF,etc),drugsuppliesanddrugaccountabilityatstudysites.• PerformsourcedataverificationaccordingtoSDVplan.Ensuredataqueryresolution.Workwithdatamanagementtoensurequalityofthestudydata.• EnsureaccurateandtimelyreportingofSeriousAdverseEvents.• SharerelevantinformationonpatientrecruitmentandstudysiteprogresswithinlocalStudyTeam.UpdateVCVandothersystemswithdatafromcentresasperrequiredtimelines• PrepareforactivitiesassociatedwithauditsandregulatoryinspectionsinliaisonwithlocalStudyTeamLeadandQA.• Additionaltasksassignedbymanager,includebutnotlimited:studyleveltasksassociatedwithCountryStudyManager(CSM),actasamentorforjuniorteammember,co-monitorlessexperienceCRAwithinstudyteam.• Contributetoprocessimprovements,knowledgetransferandbestpracticesharing.任职资格：• Bachelordegreeinbiologicalscienceorhealthcare-relatedfield,orequivalent• Minimum3-yearexperienceasCRAorotherrelatedfields.• Haveproventrackrecordonperformanceofsitemanagementandmonitoringdelivery.• Solidunderstandingoftheclinicaldataflow• Excellentknowledgeoftheclinicalstudyanddrugdevelopmentprocesses,GCP/ICHguidelinesandrelevantlocalregulations• GoodcomputerskillsinMicrosoftandothersoftware.• FluentinbothoralandwrittenEnglish.• GoodknowledgeoftheMonitoringProcess,suchasunderstandingoftheStudyDrugHandlingProcessandtheDataManagementProcess,etc.• Demonstratesabilitytoprepareanddeliverstudyrelatedtrainingmaterials• Abilityt