Role Summary
We are seeking an eCOA Study Build Programmer to design, configure, program, and test electronic Clinical Outcome Assessment (eCOA) and clinical data collection systems. The role ensures accurate study build execution, data mapping, and compliance with clinical protocol requirements while supporting end-to-end clinical trial data acquisition and reporting needs.
Key Responsibilities
- Gather and interpret eCOA design specifications to support clinical trial implementation
- Design, program, and test eCOA/eDC/eSource data collection systems and study databases
- Build and validate eCRF screens, including data entry workflows and edit checks
- Implement data repository mappings aligned with clinical data standards and study protocols
- Ensure accurate data flow from patient data capture to analysis datasets
- Collaborate with Clinical Build Programmers to deliver complete study builds
- Analyze clinical protocols and translate requirements into system specifications
- Support study-level deliverables including Data Management Plans, database setup, and study documentation
- Execute post-production changes and assess impact on study design and data integrity
- Support submission, inspection, and regulatory response activities
- Contribute to cross-functional or high-complexity study/program implementations
Required Skills & Qualifications
- Strong experience in Clinical Domain (eCOA, eDC, eSource, or Direct Data Capture)
- Proficiency in JavaScript, JSON, HTML, SpEL expressions, and C#
- Experience designing and building electronic CRF (eCRF) screens with validations
- Strong understanding of clinical protocols and clinical terminology interpretation
- Experience in clinical data systems, testing, and validation workflows
- Knowledge of clinical data standards and data mapping concepts
- Ability to analyze data flow from capture to analysis and reporting
Preferred Skills
- Experience in clinical data analytics and visualization
- Exposure to clinical data warehouse or data repository systems
- Understanding of clinical trial regulatory and submission processes
- Experience working in cross-functional clinical study teams