Job Description

JOB DESCRIPTION MinimumQualifications & Experience: Graduateininformationscienceorlifesciencerelatedfield,orsimilar.Preferablyatleast sixmonthstothreeyears\' experienceinasimilar roleinaCROor pharmaceutical company Responsibilities TheCDP-Ishallberesponsibleforprogrammingactivitiesonaproject.Thisshallinclude designing andimplementationofclinicaldatabase,programmingofdatareviewlistings andprogrammingofdatareconciliation.TheCDP-I shallensurequalitystandardsper SOPs andICH-GCP. Participates in project team meetings asrequired. 1. TheCDP-Ishallberesponsibleforprogrammingactivities on aprojectin differentclinical trial applicationsin accordancewith Novotech standards. 2. Perform databasedesignand creation of entryscreens per thedesign specifications foraproject.This will also include alpha testingbeforereleasing. 3. Mayassist in editcheckprogrammingper theeditcheck specifications fora project. This willalso include alpha testingbeforereleasing. 4. Perform data mapping/reconciliation programmingperthe data mapping/reconciliation specifications for aproject.This willalso include alpha testingbeforereleasing. 5. Perform data listingprogrammingper thedatalistingspecifications foraproject. This will also include alpha testingbeforereleasing. 6. Performs status report setup and programmingperthe status report specifications foraproject. This willalso include alpha testingbeforereleasing. 7. TheCDP-Imayberequested to providesomeprogrammingrelatedtechnical support on projects. 8. TheCDP-Imayberequested to providesometrouble shootingand problem solvingrelated to programmingon projects. 9. Perform external datasetup in clinical trial applicationsperdata transfer planand clinical trialapplication specifications. 10. Perform external dataloads, i.e. labs, ECGsetc., as needed. 11. Support theProject/ProgrammingLead on aproject on tasks as needed. 12. Ensure all programming activities and processes performed are conducted in accordancewith standardoperatingprocedures and good programmingpractices. 13. Support in thevalidation of electronicsystems,software and programs implemented in accordancewith current regulatoryrequirements.

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