Principal Clinical Database Programmer (eCOA Study Builder)
Parexel International Corporation4 days ago
Remote, India or Hyderābād, IndiaStaff+
Responsibilities
- Design, configure, maintain, revise, and close out eCOA studies based on protocols, assessment schedules, specifications, and licensed instrument requirements.
- Configure questionnaires, screens, field properties, code lists, schedules, branching logic, rules, reminders, alerts, notifications, and study settings in approved eCOA platforms.
- Coordinate eCOA configuration and controlled integration with EDC systems while maintaining alignment with CRFs and approved study documentation.
- Implement protocol amendments, production revisions, translations, and maintenance changes while protecting data integrity and traceability.
- Perform technical quality control, support UAT, create test evidence, triage defects, and coordinate deployment and post-production troubleshooting.
- Collaborate with sponsors, vendors, and cross-functional clinical research teams to resolve design issues and manage project risks, dependencies, scope, timelines, and resourcing changes.
- Maintain specifications, configuration records, test evidence, and study artifacts in compliance with SOPs, Work Instructions, ICH-GCP, and applicable regulations.
- Provide training, coaching, technical guidance, and system demonstrations to project teams and less-experienced study designers.
Requirements
- Bachelor's degree in life sciences, computer science, health informatics, clinical research, or a related discipline.
- Proven experience with eCOA, ePRO, or eDiary solutions and strong clinical research experience in a CRO or pharmaceutical setting.
- Experience with EDC systems and understanding of eCOA-to-EDC configuration dependencies and data flow.
- Knowledge of questionnaire design, schedules, branching logic, reminders, notifications, translations, version management, and participant workflows.
- Knowledge of SOPs, Work Instructions, 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, global studies, sponsors, and cross-functional teams.
- Strong communication, organization, problem-solving, root-cause analysis, risk identification, and decision-making skills.
- Proficient presentation and system-demonstration skills and written and oral fluency in English.
- Preferred: hands-on experience with Medidata Designer eCOA or comparable study-design technology and experience with Medidata Rave EDC.
Benefits
- Remote, hybrid, or on-site work options in Hyderabad or Bengaluru.
- Growth-oriented environment with continuous learning opportunities and potential career paths across clinical research.
- Opportunity to contribute to clinical trial delivery, reusable standards, and continuous improvement.
Categories
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.