职位描述
岗位职责：
iCSM = initiation Clinical Site Manager
SSU = Site Start Up
主要负责临床试验前项目启动的相关工作，准备伦理和机构的相关文件。
有CRA,SSU或者CRC工作经验。
至少1年CRA或者SSU工作经验。
或2年CRC工作经验。
任职要求：
*JobDescription
*Conductcountryspecificfeasibilityand/orsitepre-qualification
*Reviewandvalidatesiteidentificationlist
*CollectandnegotiateConfidentiallyAgreements(CDA)asrequired
*Organizetranslationspercountry/regulatory/clientrequirements
*Reviewandapprovecountryspecificand/orsitespecificdocumentsoressentialregulatorydocuments(SRP)
*Customize,review,configure,andnegotiateasrequiredcountry/sitespecificInformedConsentForms(ICF)andtheiramendments
*PrepareandsubmitIRB/IECapplicationandfollowupuntilfinalapprovalreceived(initialsubmissionandamendments)
*Prepareandnegotiateasrequiredinitialand/oramendedCSAatasitelevel
*ResolveCSAchangesrequestedbythesiteandapproveanychangeinCSAlanguagewithsupportfromSiteContractLeader(SCL)asrequired
*CollectinternalCSAsignatures
*Completeroutinedepartmentaladministrativetasksinanaccurateandtimelymanner(e.g.timesheets,metrics,etc.)
*Proactivelykeepmanagerinformedaboutworkprogressandanyissues(includingconflictingprioritiesandfreecapacity)
*MaintainaworkingknowledgeofandensurecompliancewithapplicableICH-GCPGuidelines,internationalandlocalregulations,PAREXELSOPs,otherPAREXELtrainingrequirements,andstudyspecificproceduresandtraining
*Ensureexcellentunderstandingofprojectscope,milestones,budgets,andtimecodesandstriveforhighquality,timely,andefficientdelivery
*UpdateallappropriateClinicalTrialManagementsystems(CTMS)asindicatedperfunctiononanongoingbasisandsubmitallrelevantdocumentstocentralfilespertheCentralFileMaintenancePlan
*EscalateanysiteandstudyissuesthatrequireimmediateactiontotheFunctionalLead(FL)
*Proactivelyworkwithotherprojectteammemberstomeetprojectgoals
*Showcommitmentandperformconsistenthighqualitywork
Inaddition;
*Maintainapositive,resultsorientatedworkenvironment,buildingpartnershipsandmodelingteamwork,communicatingtotheteaminanopen,balanced,andobjectivemanner
*Managecomplexsitesandprotocolsacrossmultipletherapeuticareaswithahighlevelofautonomy
*Provideinputtocountryselectionstrategy
*Supportlessexperiencedstaffonprojectassignmentsasappropriate
*RecognizeoutofscopeactivitiesandcommunicatetoFL
*Anticipateimpactofissues/delays/changesonstudytimelinesandcommunicatetoFL
*Participateininternalaudits/clientmeetingswithminimalsupervision
*Proactivelyinformmanageraboutworkprogressandanyissuestoavoidunforeseensituationsandrecommendsolutions
*RequireminimalsupervisionbyManager
*Actasfunctional/technicalSubjectMatterExpert(SME)asrequired
*Identifyinconsistenciesandinefficienciesinprocesses/systems/trainingsandrecommendsolutions
*Participateininternalandexternalprocessimprovementinitiatives
*JobQualifications
*Excellentpresentationskills
*Clientfocusedapproachtowork
*Abilitytointeractprofessionallywithexternalcustomers
*Flexibleattitudewithrespecttoworkassignmentsandnewlearning
*Advancedabilitytomanagemultipleandvariedtaskswithenthusiasm
*Attentiontodetail
*Abilitytoworkinamatrixandvirtualteamenvironmentandtovaluetheimportanceofteamwork
*StrongcomputerskillsincludingbutnotlimitedtotheknowledgeofClinicalTrialManagementSystems(CTMS),ElectronicDocumentManagementSystem(EDMS),andMS-OfficeproductssuchasExcelandWord
*Excellentinterpersonal,verbal,andwrittencommunicationskills
*Advancedproblemsolvingskills
*Senseofurgencyincompletingassignedtasks
*Excellenttimemanagementinordertomeetdailymetrics,teamobjectivesanddepartmentgoals
*Provenabilitytoworkacrosscultures
*Excellentabilitytoworkindependentlybutseekguidancewhennecessary
*ExcellentabilitytoinfluenceandnegotiateresolutionsandoutcomeswithsitesandIRBs/IECs
*Willingandabletotravellocallyandinternationallyoccasionallyasrequired
Education
*Educatedtodegreelevel(biologicalscience,pharmacy,orotherhealth-relateddisciplinepreferred),nursingorotherrelevantqualification/experience
LanguageSkills
*ExcellentwrittenandoralEnglishandfluentinrelevantlocallanguage
MinimumWorkExperience
*Substantialpreviousclinicaltrialstart-upexperienceorequivalentexperienceinclinicalresearchwithstrongunderstandingofclinicaltrialsmethodologyandterminology
