Clinical Database Developer
$125,000–$150,000 year
On-siteFrederick, Maryland, United States
Job Summary
Design, develop, test, validate, and maintain study-specific electronic data capture (EDC) databases ensuring compliance with FDA regulations, ICH E6, GCDMP, and CDISC/CDASH standards. Create and maintain CDASH-annotated Case Report Forms (CRFs), develop specifications, and perform User Acceptance Testing (UAT) and system validation activities. Implement edit checks, derivations, and quality control procedures while supporting database change management and version control processes. Generate data extracts, listings, and reports to support database lock activities and preparation of submission-ready datasets. Collaborate with Clinical Trial Managers, Data Managers, SAS Programmers, and Biostatisticians throughout the FDA-regulated medical product development lifecycle.
Required Qualifications
- Bachelor's degree in Computer Science, Information Systems, Health Informatics, Clinical Research, or related field
- Minimum 5 years of clinical database development experience
- Experience with EDC systems and clinical trial databases
- Knowledge of FDA-regulated clinical research and CDISC standards
- Ability to obtain required DoD security credentials
- CompTIA Security+ certification or ability to obtain within required timeframe
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