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 guidan