Qualifications:
•5+ years of EDC database build experience for clinical trial.
•Experience with Medidata Rave with Medidata certification; Minimum two to three years current database programming experience designing studies and data validation programming in Medidata Rave.
•Is able to write the code at CF from scratch.
•Familiarity with clinical data regulations (GCP, ICH).
•Familiarity with Operational Qualification/Performance Qualification and UAT execution and documentation.
•BS or MS degree in related discipline.
Responsibilities:
•Build and design clinical study trials in Medidata RAVE system.
•Design/create and test clinical databases including forms, folders, matrices, data
dictionaries/code lists, unit dictionaries, edit checks/rules, derivations, custom functions, standard and custom reports.
•Provide programming expertise to support data capture, review, and monitoring for clinical trials.
•Program reports, edit checks, and custom functions based on study protocol requirements.
•Assist with EDC integration with other systems, including but not limited to IRT system, CTMS system and etc.
•Manage external vendor data import and validation.
•Provide technical support as needed for Medidata RAVE and Merative Zelta EDC systems.
•Participate in EDC design requirements development in collaboration with Study Lead Data Manager and the wider study team.
•Support development of and updates of global library objects as appropriate according to best practices and new standards.
•Perform peer review for the studies built by other programmers.
•Maintain all required Clinical Systems study documentation.
•Provide EDC technical support to facilitate study timelines and deliverables.
•Manage timely-quality deliverables for the study teams for assigned protocol/study(s).
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