eCOA Build Programmer

Job summary:

The electronic Clinical Outcomes Assessment (eCOA) Build Programmer is responsible for designing, programming, and testing clinical trial data collection databases, including data mapping, testing, and normalization into a clinical data warehouse. This role requires a strong understanding of data technologies, data standards, database programming, and validation processes. The eCOA Build Programmer collaborates closely with study teams to deliver standardized and innovative data collection solutions for global clinical trials.

Key responsibilities:

• Gather and influence eCOA design specifications to enable successful clinical trial implementation.
• Program and test data collection systems and associated data warehouse mappings using standard library components.
• Ensure accurate, efficient delivery of data collection systems aligned with study objectives.
• Partner with Clinical Build Programmers to ensure complete end-to-end data build coverage.
• Provide input into study-level deliverables including Data Management Plan, project plan, databases, and observed datasets.
• Support submission activities, regulatory inspections, and response preparation.
• Lead cross business unit or therapeutic area projects with high complexity.
• Analyze and implement post-production study design changes.

Required skills & experience:

• Hands-on experience as a programmer in eCOA, eDC, eSource, or direct data capture implementations.
• Experience designing electronic CRF screens and building required data validations.
• Strong understanding of clinical protocols and clinical terminologies to create design specifications.
• Familiarity with clinical data tools, workflows, testing, and validation processes.
• Ability to articulate end-to-end data flow from patient data capture to analysis.
• Experience in data analytics and visualization.
• Experience deciding appropriate technology platforms for data acquisition and aggregation.

Languages needed:

• Programming experience with HTML, CSS, JavaScript, Node.js, JSON, and SpEL.
• Experience with relational and non-relational databases using SQL, data functions, and procedures (e.g., MongoDB).
• Strong understanding of database structures and data mapping concepts.
• Experience using GitLab utilities.

Competencies:

• Clinical data systems and standards
• Data modeling and normalization
• Analytical thinking and problem solving
• Cross-functional collaboration
• Leadership and communication skills

Preferred skills:

• Veeva EDC and/or RAVE (required).
• Core Java knowledge (plus).
• Ability to quickly learn new and emerging technologies.
• Demonstrated leadership and teamwork in professional environments.