Positionoverview:Thisroleisresponsibleforcomprehensivetrialandsiteadministration.UndertheoversightoftheSeniorCOMorCOMs,thepersonprepares,collates,distributesandarchivesclinicaldocuments.TheroleiscriticaltomeetplannedSiteReadydates,therolewillcollaborateatlocallevelcloselywithCOM,CRMandCRA.Andthepersoncollaborateswithfinance/budgetingrepresentativestomanageCTRAsandpayments.Responsibilities:Regulatory&SiteStart-Upresponsibilities:Collaboratewithothercountryrolesto:-Obtain,trackandupdatestudyinsurancecertificates-Budgeting,AgreementandPayments:-Collaboratewithfinance/budgetingrepresentativesfor:-Develop,control,updateandclose-outcountryandsitebudgets(includingSplitsitebudget)-Develop,negotiate,approveandmaintaincontracts(e.g.CTRAs)-Trackandreportcontractnegotiations-Updateandmaintaincontracttemplates(incooperationwithLegalDepartment)-Calculateandexecutepayments(toinvestigators,vendors,grants)-Ensureadherencetofinancialandcomplianceprocedures-Monitorandtrackadherenceanddisclosures,-Maintaintrackingtools-OverseesFCPA,DPS/OFAC,andmaintenanceoffinancialsystems.Youwillhave:CORECompetencyExpectations:-FluentinLocalLanguagesandbusinessproficientinEnglish(verbalandwritten)andexcellentcommunicationskills-GoodunderstandingofGlobal,Country/RegionalClinicalResearchGuidelinesandabilitytoworkwithintheseguidelines.-HandsonknowledgeofGoodDocumentationPractices-GoodITskills(UseofMSoffice,useofsomeclinicalITapplicationsoncomputer)andabilitytoadapttonewITapplications.StrongMSExcelskillsrequired.-ICH-GCPKnowledgeappropriatetorole-ExcellentnegotiationskillsforCTCsinfinanceareaBehaviouralCompetencyExpectations:-Effectivetimemanagement,organizationalandinterpersonalskills,conflictmanagement-Effectivecommunicationwithexternalcustomers(e.g.sitesandinvestigators)-Highsenseofaccountability/urgency.Abilitytosetprioritiesandhandlemultipletaskssimultaneouslyinachangingenvironment-Workseffectivelyinamatrixmulticulturalenvironment.Abilitytoestablishandmaintainculturallysensitiveworkingrelat
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