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Clinical Data Programmer

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• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance. • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. • Travel (approximately 0%) domestic and/or international. CDMS: • *Participates in study specific database set-up within at least one CDMS system (i.e. Oracle RDC, Oracle Inform, Medidata Rave, DataTrak UX EDC, Oracle Clinical and CRF WorkManager) • *Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS). • *Builds clinical study database CRF/database screens per CRF/database Specifications provided by Clinical Data Programming Leads. • *Creates/Programs edit checks, special actions and derivations as per a DVS. • *Works closely with centralized CDMS Validation Group to ensure all programming issues are resolved in a timely manner and study timelines are met • *Completes and maintains all study documentation as per ICON procedures • *Completes study database updates as specified per Change Request documents and procedures. • *Trouble-shoots and solves study building issues and edit check programming issues. • May participate in study team meetings as an ad hoc study team member. • Attends sponsor audits and assists with in-progress audits, as needed. • To participate and contribute towards internal user group meetings to share knowledge and providing latest updates/features . Participate in Data Management department initiatives. • Ensures all queries are responded to in a timely manner. Ensures that queries that cannot be resolved are routed to the correct SME and the issue is pursued until resolved. • Ensures programming processes are compliant with applicable SOPs. • Ability to retrieve raw datasets. • Other responsibilities may be assigned as required. CDS: • *Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data sets. • *Create data set specifications per specified study requirements. • *Program data sets per specification . • *Validate data sets per the formal, documented QC process. • *Create data programming specifications per specified study requirements. • *Program clinical data programs per specification . • *Validate clinical data programs per the formal, documented QC process.
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