Job description

Design and build clinical study databases in alignment with protocol requirements and industry standards. Develop eCRFs, edit checks, derivations, custom functions, and data review listings. Collaborate with cross-functional teams including Clinical Data Managers, Biostatisticians, and Clinical Operations. Support User Acceptance Testing (UAT) and resolve study build issues. Ensure adherence to CDISC/CDASH standards and regulatory compliance (e.g., FDA 21 CFR Part 11). Maintain and update study build documentation including specifications, configuration guides, and change logs.

Skills Required

Key Skills

• MEDIDATE RAVE
• STUDY BUILD
• EDIT CHECK PROGRAMMING
• DATABASE DESIGN
• UNIT TESTING

Other Information