Thecoreresponsibility forthispositionisas amemberofthe DataManagement departmentatNovotech.TheClinicalDataProgrammer-I(CDP-I)willberesponsiblefor programmingactivitiesonclinicaltrialprojectsandtoensurecompliance withGood Clinical Data Management Practices (GCDMP).
TheCDP-IshallberesponsibleforprogrammingactivitiesonaprojectThisshallinclude designing andimplementationofclinicaldatabases,programmingofdatareviewlistings andprogrammingofdatareconciliationTheCDP-I shallensurequalitystandardsper SOPs andICH-GCP
Particate in project team meetings as required.
The CDP-I shall be responsible for programming activities on a project in different clinical trial applications in accordance with Novotech standards.
Perform database design and creation of entry screens per the design specifications for a project. This will also include alpha testing before releasing.
May assist in editing check programming per the edit check specifications for a project. This will also include alpha testing before releasing.
Perform data mapping/reconciliation programming per the data mapping/reconciliation specifications for a project. This will also include alpha testing before releasing.
Perform data listing programming per the data listing specifications for a project
This will also include alpha testing before releasing.
Performs status report setup and programmingperthe status report specifications foraproject. This willalso include alpha testingbeforereleasing
TheCDP-Imayberequested to providesomeprogrammingrelatedtechnical support on projects.
TheCDP-Imayberequested to providesometrouble shootingand problem solvingrelated to programmingon projects.
Perform external datasetup in clinical trial applicationsperdata transfer planand clinical trialapplication specifications.
Perform external dataloads, i.e labs, ECGsetc., as needed.
Support theProject/ProgrammingLead on aproject on tasks as needed.
Ensure allprogrammingactivitiesandprocessesperformedare conducted inaccordancewith standardoperatingprocedures and good programmingpractices.
Support in the validation of electronic systems, software and programs implemented in accordancewith current regulatoryrequirements.
Graduateininformationscienceorlifesciencerelatedfield,orsimilar.Preferablyatleast sixmonthstothreeyears’ experienceinasimilar roleinaCROor pharmaceutical company
Knowledge of clinical study protocol, hands on / learning experience in Medidata RAVE, Veeva and Viedoc and other market EDCs is preffered. Also, SQL, Phython, HTML, .NET, C# coding is required
Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company that provides biotech and small- to mid-sized pharma companies an accelerated path to market since 1997. With a global footprint spanning 30+ offices across the Asia-Pacific region, North America, and Europe, and partnerships with 5,000+ trial sites, Novotech offers unparalleled access to key clinical trial destinations and diverse patient populations.
Novotech leverages its therapeutic and regulatory expertise, client-centric service model, local market insights, and advanced analytical tools to expedite patient recruitment, enhance trial efficiencies, and bring life-changing therapies to market faster. This work has been recognized by awards such as the Frost & Sullivan CRO Company of the Year, which Novotech has received for 19 consecutive years.
For more information or to speak to an expert team member visit www.Novotech-CRO.com
