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:http://bbs.pku.edu.cn/bbs/bbstcon.php?board=HSC&threadid=15186099
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MSD
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3MappingProgrammer
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StellaLinjing.lin1@merck.com
1.(
Department:MRL,GDMSChinaDMC
Reportto:Manager,ClinicalDataMgmt
Location:Beijing,China
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2.ClinicalDataSpecialist/(
Department:MRL,GDMSChinaDMC
Reportto:Manager,ClinicalDataMgmt
Location:Beijing
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3.MappingProgrammer
JOBDESCRIPTION
MappingProgrammer
Department:
GCD,GCTO,GDMS,GCDI,RaM
Division/Area: MRL
Reportsto(Title):
AssociateDirector
(AssociateManager,Manager,SeniorManager,AssociateDirector,DirectorI/I
IChina)
PositionOverview
UnderthedirectionoftheAssociateDirector/Manager,theMappingProgrammer
supportforthesetupandmapping,testing,andmodificationofprogramsto
flowdatafromthecollectionsourcetotheClinicalDataRepository.Demons
tratesaworkingknowledgeofCDISCstandards(SDTM,ODM)andETLtoolstotr
ansferdatainsupportofclinicalresearch.PrimarycustomersareGlobalDa
taManagementServices,GlobalSafety,ScientificProgramming,andClinicalR
esearch.ProvidesexpertisefortheprocessesandtoolsutilizedbytheMapp
ingStaff.SupportsthedocumentationforSDLCincludingreportinganddocum
entingtestingresults.AllincompliancewithMerckStandardOperatingProc
edures(SOPs)andICHGCPguidelines.
PrimaryActivities
Primaryactivitiesinclude,butarenotlimitedto:
AssumestheresponsibilitiesforalldatamappingdeliverablesincludingSDTM
structuresetupandtransformationmapstosupportmultipleclinicalprogra
ms.Coordinatesandparticipatesinthefollowingactivities:
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75%
Design,build,maintain,test,anddocumentdatamappingspecificationsb
asedonclinicaldatabasestructuresestablishbyGlobalClinicalDataManage
mentandClinicalResearch.MappingspecificationsmustmeetSDTMstructure
requirementsutilizingCLMMandE2Evisibilitytoolstoensurequalityandti
melinessofdataflowtotheClinicalDataRepository.
20%
Performongoingsupportfordataflow.ChangeRequestsandIncidentRepo
rtsarefullydocumented,signedoff,tracked,andreportedtouppermanageme
nt.
5%
Participateinprocessimprovementinitiatives,departmentalmeetings,and
specialprojects.
Requirements
Education:
1.
Bachelorsdegreeincomputerscienceorequivalenteducationalexposure
tosoftwaredesignanddevelopmenttheory,techniques,testingmethodologies,
andsoftwaredocumentation.
KnowledgeandSkills:
2.
o
o
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Atleast1yearto2yearsexperiencein
CDISCStandards,(SDTM,CDASH,Define.xml)
SQL,PLSQL,XML,Java
ELTtools,preferablyContivo
3.
ExpectedtohaveastrongtechnicalproficiencyinaClinicalDataManagem
entSystem.ParticularlyInform,DataLoading,DataTransformations.
4.
SolidknowledgeofMSWindows/Officesoftwareandexposuretowebbasedap
plications.
5.
WorkingknowledgeofSystemDevelopmentLifecycleManagement/systemvali
dationknowledge
6.
Abilitytoestablishandmaintaingoodworkingrelationshipswithdifferen
tfunctionalareas.
7.
Strongsenseofurgencyandcustomerfocus.
8.
Strongorganizationalandproblemsolvingskills.
9.
Desireandabilitytolearnnewprocessesandtechnologies
10.
Abilitytomultitask,workindependently,andgoodcommunicationskills
11.
Understandingofdrugdiscoveryprocess,FDAregulations,GxPguidelines,
ICHguidelines,clinicaldatabasecleaningprocess,and21CFRPart11.
201496
:bdwm.net[FROM:211.71.49.229]
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