Primary Job Responsibilities: Create and review (electronic) Case Report Forms perProtocol and annotated Case Report Forms Review Protocols to ensure database feasibility Develop/build, review, and maintain a clinical database andsupporting specifications documentation Develop/build, document and perform validation of databasestructure, data capture screens, code lists, edit checks, reports and otherfunctions in EDC (e.g. User Acceptance Testing) Develop data transfer agreements and specifications withvarious vendors Write, review and maintain eCRF completion guidelines, datamanagement plan (DMP), data validation plan (DVP, e.g. edit checks), and otherDM related documentation Perform all aspects of DM process as related to processingand QC of the data Clean data for study close out and perform all database lockprocedures
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