iCSM 臨床項目啟動專員（SSU）

職位描述

崗位職責：

iCSM = initiation Clinical Site Manager

SSU = Site Start Up

主要負責臨床試驗前項目啟動的相關工作，準備倫理和機構的相關文件。

有CRA,SSU或者CRC工作經驗。

至少1年CRA或者SSU工作經驗。

或2年CRC工作經驗。

任職要求：

*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