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Clinical Programmer Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Works as part of a project team to design and implement clinical database applications in support of clinical research and biostatistics analysis. Works with clinical data managers and biostatisticians to develop database build specifications and gain acceptance through user testing. Develops data entry screens and programs, and data quality edit checks to comply with related specifications. Accomplishes database structure testing. Processes database programming change requests. Documents all work fully according to FDA regulations and guidances, and company SOPs. Communicates database build, edit check programming and related document review statuses to management and the project teams. Primary Responsibilities Assist in developing, validating, and maintaining clinical databases for clinical trials using a variety of validated software applications Provide complete and accurate documentation of study databases consistent with company standard operating procedures (SOPs), study protocols and related data management plans Build and validate data entry screens (paper and/or electronic data capture (EDC)) Implement and test data quality checks in accordance with the study data validation manual Utilize copies of like database elements from library structures or other similar studies during builds Assist in batch loading external data from vendors (e.g., central lab data) Assist in management of user access to clinical databases Participate in writing departmental documentation (e.g., training documents, process guidances) Participate in other clinical programming and data management activities, as required Adhere to all aspects of the SDC’s quality system Comply with SDC’s data integrity & business ethics requirements Perform other duties as assigned Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.