Principal Clinical Database Programmer – eCOA

Overview

In this role you design, configure and maintain eCOA studies to capture high-quality clinical outcomes data. You work across projects and with cross-functional teams to translate protocols into patient-, caregiver-, and clinician-facing electronic forms and workflows. You ensure data integrity through testing, validation and compliant deployment of eCOA configurations with EDC integration. You will guide stakeholders, provide technical expertise, and help drive efficient, compliant study delivery from design to post-production support. This is a fully home-based opportunity across the UK, offering meaningful impact on patient outcomes.

Responsibilities

• Design, set up, maintain, revise and close out eCOA studies, translating protocols into electronic data collection workflows
• Configure questionnaires, screens, field properties, code lists, schedules, activities and branching logic in the approved eCOA platform
• Coordinate initial eCOA configuration and push to EDC; align eCOA config with EDC draft and CRF versions
• Perform technical quality control of eCOA configurations against specifications and prepare materials for UAT
• Support pre-UAT, UAT execution, defect triage and resolution; manage deployment readiness and post-production support
• Collaborate with Clinical Database Programming, Data Management, eCOA Clinical Data Analysis, COA Science, Clinical Operations and other study functions to finalize requirements
• Lead or participate in design and build meetings, provide configuration status, identify risks and dependencies
• Interact with sponsors and vendors as technical contact for eCOA design, testing and deployment
• Provide input to study timelines, monitor work and communicate changes in scope or resourcing
• Create and maintain eCOA specifications, configuration records, test evidence and other study artifacts
• Maintain study documentation to support traceability, inspection readiness and regulatory compliance
• Develop and maintain standards, reusable libraries and templates to improve eCOA delivery quality and efficiency
• Provide training and technical guidance to project teams and assist in resolving complex issues
• Provide technical input to proposals, effort estimates and client presentations

Key requirements

• Bachelor in life sciences, computer science, health informatics, clinical research or a related discipline
• Written and oral fluency in English
• Proven experience with eCOA, ePRO, eDiary
• Strong clinical research industry experience (CRO/Pharma)
• Hands-on experience configuring an eCOA platform (e.g., Medidata Designer eCOA) or comparable study-design technology
• Knowledge of questionnaire design, schedules, branching logic, reminders, translations and version management
• Experience with EDC systems (preferably Medidata Rave) and understanding of eCOA-EDC data flow
• Knowledge of SOPs, system life-cycle methodologies, ICH-GCP, 21 CFR Part 11 and regulatory requirements
• Experience with technical quality control, UAT, defect management and validated clinical systems
• Experience supporting global studies and cross-functional teams
• Strong collaboration, independent work across time zones and excellent communication skills
• Ability to translate protocols into system configurations and to explain technical decisions to non-technical audiences
• Proven problem-solving, risk identification and decision-making in ambiguous situations

• collaboration across global teams
• clear and effective communication
• problem solving and root-cause analysis
• eCOA
• ePRO
• eDiary

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