Clinical Trial Assistant for top 5 pharma社

6K-8K/月

上海市本科及以上1年及以上

发布时间：2023-09-06

职位描述

职位描述：

JobDescription

AdministrationandClinicalOperationSupport:

SupportthemaintenanceofstudyTrialMasterFiles(sTMF)andanyotherinternalreportingsystems,asapplicable
Assistinthepreparationofsubmissionfiles
Preparedocumentationforcloseoutandarchivein-housefiles
Arrangefordestructionof‘non-archive’materialspoststudy
AssistClinicalDevelopmentDirector(CDD),Sr,ClinicalDevelopmentManager(Sr.CDM),ClinicalDevelopmentOfficer(CDO)asrequiredtorunrelevantreports
Responsiblefortheupdatingofclinicalresearchrelatedsystems,e.g.IMPACT,PCE
Supportlogisticsupportforsitesafetymailingethicalcommittee(EC)submission
SinglecontactforinternalaffiliatePOapplication,placepaymentrequestforsiteand/orTPObasedonagreedcontract
ProvideoperationalsupportinlocalIIT,includepreparingIITstudycontractand/orIPbasedoninternalapprovedIITproposal,trackingIITenrollmentprogress,coordinatingIPdistributiontositeandprocessingsitepayment,ifapplicable
CoordinatelocalsitestudyequipmentleasingprocessIfapplicable,assistinmeetinglogisticsandpreparationofpresentations
Ifapplicable,supportCDD,Sr.CDM,CDOinadministrativetask,dependingonlocalsituation,eg.Coordinationandset-upofmeetings,agenda,minutes,travelarrangements,couriering,postdutiesetc.

IP/non-IPOperationSupport(foraffiliatewithTPOmanagedwarehouse):

SourcingofIP(commercialmaterial)andnon-IPsupplies
SupportManagementofIPandnon-IPsupplies(in-housewarehouse/externaldeviations),ensureadequatestorageconditionsandaccountability,reportdeviationsandfollowuponresolution
Manageinventoryandre-supply,asapplicable
Managementofimport/exportactivitiesrelatedtoIP/non-IPsupplies
Coordinateshipment/return/destruction
ProvideIPdistributionmanagementtrainingtoCRAs

JobRequirements:

EducationinBusinessadministrationorhealthcarerelatedfields
IfapplicableclinicalresearchexperienceStrongorganizational,analyticalandproblem-solvingskill
Excellentwrittenandverbalcommunication,andpresentationskills
Abilitytoworkaccordingtostrictdeadlines,prioritizeandmanagemultiplecustomers
Excellentteamwork/interpersonalskills
Demonstratedabilitytooperateandinfluenceacrossfunctionsandbusinessareas
Excellentcustomerrelationshipskills
FluencyinbothverbalandwrittenEnglish

其他要求

招聘人数：5人
职能类别：

公司介绍

InJan2014,ChoicePharma(丘以思(上海)医药信息咨询有限公司)mergedwithClinipaceWorldwide.ClinipaceWorldwideisaglobalfull-servicedigitalcontractresearchorganization(dCRO)thathaspioneeredaninnovativeservicemodeltotransform
drugandmedicaldevicedevelopmentbydeliveringtechnology-amplifiedservicestoimprovestudyperformance,collaboration,andtransparencyacrossallstakeholders.Frommanagingyourentiredevelopmentprogramtoconductinganindividualclinicaltrial,ourexpertsbringextensivetherapeuticandlocalexperienceinbuildingawell-definedclinicalplantomaximizeyoursuccess.PoweredbyTEMPO?–ourproprietaryeClinicaltechnology–ourteamsensureyoursuccessandbringunsurpassedefficiency,quality,andvisibilitytoyourdevelopmentprograms.
NowClinipaceWorldwideranksthe10thCRO,anddevelopesrapidly.