associate data manager社

20K-30K/月

上海市本科及以上

发布时间：2023-09-06

职位描述

职位描述：

PrincipleResponsibilities:
1.TakesaleadershiprolewiththeCRO,thetrialcustomer(s)andotherinternalandexternalpartnerstoestablish,alignandconfirmdatamanagementexpectationsforassignedtrial(s).
2.Withthetrialcustomer,CROandotherfunctionalpartners:
a.GatherscontentandintegrationrequirementsforeCRFandotherdatacollectiontools.
b.Establishesconventionsandqualityexpectationsforclinicaldata.
c.Establishesexpectationsfordatasetcontentandstructure.
d.Settimelinesandfollow-upregularlytoensuredeliveryofallDataManagementmilestones.
3.Performstrialleveloversightcontrolsasdescribedintheoversightplan,QCprocessandworkinstructionswithminimalDMLdirection.
4.Reviewsclinicaldatamanagementdocuments(includingsubmissionpackage)ensuringappropriatequality,scientificcontent,organization,clarity,accuracy,formatandconsistency.Ensurescompliancewithregulatoryguidelinesandthedocumentationmatrix.
5.Ensuresreal-timeinspectionreadinessofallIDSdeliverablesforthetrial;ParticipateinRegulatoryAgencyandJ&Jinternalauditsasnecessary.
6.Plansandtrackscontent,format,quality,andtimingofdatamanagementdeliverables,including,butnotlimitedto,CRF,datareviewplan,QCplan,oversightplan,databasereleaseplan,finaldatasets,submissionplanandarchival.Ensuresdeliverablesareontime.
7.Takesaleadershiprolewiththeassignedclinicalworkinggroup(s)toensurethatIDSandTAtrialneedsanddeliverablesaremet.
8.Identifiesandcommunicateslessonslearned,bestpracticesandfrequentlyaskedquestionsatthetriallevel.
9.Identifiesandparticipatesinprocess,system,andtoolimprovementinitiativeswithinIDS.
10.Presentsandtrainsatinvestigatorandmonitormeetings
11.PotentialAcceleratoropportunities(Itisimportantthatyouareeffectiveinachievingyourcurrentgoalsandobjectives,priortoengaginginacceleratorexperiences)
a.Buildspecificdomainexpertise(e.g.,contracts,budget,etc.).
b.Remaincurrentwithnewandchangingdevelopmentsindatamanagementandsharewithcolleagues.
c.Remaincurrentwiththeregulatoryenvironmentinclinicaltrialsandproactivelyshareknowledgewithcolleagues.
d.Driveconsistencyforanactivityacrossadrugprogram(e.g.,labprocessing).
e.Volunteerforaleadershiproleinaprojectoractivity.
f.Makepresentationstoseniorlevelmanagementforenhancedvisibility.
g.Takealeadershiproleinaprocessimprovementinitiative.
h.VolunteertomentoraGlobalDataManageratthetriallevel.

PrincipleRelationships:
?Supervisionreceived:Workisreceivedinbroadterms.Workisreviewedduringmajordeliverables.Amountofinstructionislimited.WorkisreviewedwiththeDataManagerLeadersaswellaswiththeimmediatemanager.
?Supervisiongiven:Therearenodirectreportsforthisposition.ThispositioncollaborateswithVendors/CROstoachievesuccessful,cooperativepartnerships.ThispositionmaydelegatetasksandassignmentstoGlobalDataManagers.TheSeniorGDMrecognizesopportunitiesandcontributestosolutionstostrengthenthevendor/CROrelationship

其他要求

招聘人数：2人
职能类别：数据库建设

公司介绍

RPSInc.isanextgenerationglobalCRO,headquarteredintheUnitedStateswiththeoperationsin45countriesthroughoutAmericas(US,Canada,LatinAmerica),EMEAandAsiaPacificregions.RPSprovidescomprehensiveglobalPhase1-4clinicaldevelopmentsolutionstothepharmaceutical,biotechnologyandmedicaldeviceindustries.Bycombininganexperiencedclinicalresearchoperationsinfrastructurewiththeindustry’slargestresourcingengines,RPSisuniquelypositionedtoofferourClientsbothintegratedandfullserviceglobaloutsourcingsolutions.Thesesolutionsarepoweredbyhighlyexperiencedandseasonedstudyteamsprovidinginnovative,cost-effectiveandhighqualityservices.