Principal Clinical Database Programmer - eCOA
Parexel International Corporation1 day ago
Remote, United KingdomStaff+
Responsibilities
- Design, configure, maintain, revise, and close out eCOA studies based on protocols, assessment schedules, specifications, and licensed instruments.
- Configure questionnaires, screens, fields, code lists, schedules, activities, branching logic, rules, reminders, alerts, notifications, and study settings.
- Coordinate eCOA configuration and integration with EDC systems while maintaining alignment with draft EDC and CRF versions.
- Perform technical quality control, prepare test evidence and demonstrations, support UAT and defect resolution, and coordinate deployment readiness.
- Collaborate with sponsors, vendors, and cross-functional clinical study teams to resolve design issues, manage risks, and communicate status.
- Create and maintain specifications, configuration records, implementation checklists, test evidence, issue records, and version documentation.
- Provide technical advice, training, coaching, subject-matter expertise, continuous-improvement input, and business-development support.],
- requirements
Requirements
- Bachelor's degree in life sciences, computer science, health informatics, clinical research, or a related discipline.
- Proven experience with eCOA, ePRO, and eDiary, plus strong clinical research industry experience in CRO or pharmaceutical environments.
- Hands-on experience with an eCOA platform such as Medidata Designer eCOA or comparable study-design technology is preferred.
- Knowledge of questionnaire design, schedules, branching logic, reminders, notifications, translations, version management, and participant workflows.
- Experience with EDC systems, preferably Medidata Rave, and understanding of eCOA-to-EDC configuration dependencies and data flow.
- Knowledge of SOPs, system life-cycle methodologies, ICH-GCP, 21 CFR Part 11, and applicable regulatory requirements.
- Experience with technical quality control, UAT, defect management, change control, validated clinical systems, and global studies.
- Strong communication, presentation, problem-solving, root-cause analysis, risk-identification, decision-making, collaboration, and customer-facing skills.
- Fluency in written and spoken English and the ability to work independently across multiple time zones and cultures.
Benefits
- Fully home-based opportunity open to candidates across the UK.
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About Parexel International Corporation
Parexel International Corporation is a contract research organization that designs and runs clinical trials and provides regulatory and product-development consulting for biopharma and medical device companies. Its services span early-phase through late-phase studies, eClinical solutions, patient recruitment, and pharmacovigilance, delivered under fee-for-service and full-service outsourcing models. The company is privately held and headquartered in Raleigh, North Carolina.