Database Programmer
E
EDETEKClinical Data Management
United States. Brazil. ArgentinaFull-Time
Salary not disclosed
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Job Details
- Required Skills
- GCPMicrosoft Excel
Requirements
- Bachelor’s degree in life sciences, computer science, information systems, statistics, data management, or a related field.
- Hands-on experience building clinical study databases in Medidata Rave, Rave EDC, or similar eClinical systems.
- Experience with CRF design, edit check programming, database testing, and UAT support.
- Good understanding of clinical trial processes and clinical data management activities.
- Familiarity with GCP, 21 CFR Part 11, and computerized system validation principles.
- Strong attention to detail and ability to follow specifications and controlled processes.
- Good communication skills and ability to work with data management, clinical operations, programming, QA, vendors, and sponsor teams.
Responsibilities
- Build and configure study databases in Medidata Rave or other eClinical platforms based on protocol and sponsor requirements.
- Develop and maintain edit checks, derivations, and custom functions according to approved specifications.
- Review clinical protocol and CRF design requirements, identifying inconsistencies.
- Support user acceptance testing (UAT), including test script development, execution, and defect resolution.
- Collaborate with data managers, clinical operations, programming, and QA teams.
- Ensure database activities comply with GCP, 21 CFR Part 11, and audit trail expectations.
- Support production database updates, amendments, and study migration activities.
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