eCOA Programmer

Position Overview

• The eCOA Build Programmer is responsible for designing, programming, testing, and implementing clinical trial data collection systems and databases.
• Develop and maintain data collection solutions, including data mapping, testing, normalization, and integration into clinical data warehouses.
• Apply strong knowledge of data technologies, database programming, data standards, data flow, normalization, and validation.
• Collaborate with global study teams to deliver standardized data collection methods and innovative validation solutions for clinical trials.

Key Responsibilities

• Gather, analyze, and influence eCOA design specifications to support successful clinical trial implementation.
• Program and test electronic data collection systems and associated data repository mappings for individual trials or trial programs.
• Utilize data standards library components to ensure consistent and efficient system development.
• Ensure data collection systems and clinical data warehouse mappings are accurate, efficient, and aligned with study objectives.
• Partner with Clinical Build Programmers to ensure complete and accurate data builds for trial requirements.
• Provide technical insights and support for study-level deliverables, including:
  • Data Management Plans
  • Project Plans
  • Clinical databases
  • Observed datasets
• Support regulatory submissions, inspections, audits, and regulatory response activities.
• Lead complex, cross-functional projects across Business Units and Therapeutic Areas.
• Design electronic CRF screens for clinical data collection and implement required validation rules.
• Interpret clinical protocols and clinical terminology to develop technical and functional specifications.
• Analyze the impact of post-production study design changes and implement required system updates.
• Define and document end-to-end data flows, including data structure and format from patient data collection through analysis.
• Evaluate and select appropriate technology platforms, databases, and systems for data acquisition and aggregation.
• Apply data analytics and visualization techniques to support clinical data solutions.
• Participate in system testing, validation, troubleshooting, and quality assurance activities.

Required Technical Skills

• Hands-on programming experience with eCOA, eDC, eSource, or Direct Data Capture (DDC) platforms.
• Strong experience with:
  • HTML
  • CSS
  • JavaScript
  • Node.js
  • JSON
  • SpEL
• Experience with relational and non-relational databases.
• Strong proficiency in SQL, database functions, stored procedures, and data manipulation.
• Experience with NoSQL technologies such as MongoDB.
• Knowledge of data mapping, database structures, data normalization, and data integration.
• Experience working with GitLab and related version-control utilities.
• Familiarity with clinical data tools, technologies, workflows, testing, and system validation.
• Ability to understand and implement clinical data standards and standardized data collection methods.
• Strong understanding of the end-to-end clinical data lifecycle, from patient data capture through downstream analysis.

Clinical & Domain Knowledge

• Understanding of clinical trial protocols and clinical data requirements.
• Ability to translate clinical requirements into technical specifications and system designs.
• Knowledge of clinical terminology and electronic clinical data collection processes.
• Experience supporting clinical data management and clinical trial technology workflows.
• Understanding of data requirements for regulatory submissions and inspections.

Leadership & Soft Skills

• Strong leadership and decision-making skills in a professional environment.
• Excellent written and verbal communication skills.
• Strong interpersonal and stakeholder-management skills.
• Demonstrated ability to work effectively in cross-functional and collaborative teams.
• Ability to lead high-complexity projects across Business Units and Therapeutic Areas.
• Strong analytical and problem-solving abilities.
• Demonstrated ability to quickly learn and adapt to emerging technologies and industry trends.