Senior Clinical Database Programmer - eCOA

Parexel • Raleigh, NC

1d • Remote

About The Position

Parexel is seeking a remote Principal Database Programmer (eCOA Study Builder/Designer) based anywhere in the continental United States. The role provides technical expertise in designing, configuring, testing, deploying, and maintaining electronic Clinical Outcome Assessment (eCOA) solutions for clinical trials. The programmer translates protocols, assessment schedules, and licensed instrument requirements into compliant participant-, caregiver-, and clinician-facing questionnaires, schedules, and workflows.

The position supports study execution, regulatory compliance, and clinical data accuracy. It includes configuring and testing eCOA studies in approved platforms, supporting integration with Electronic Data Capture (EDC) systems, and contributing to study delivery from design through closeout. The role works across multiple projects and collaborates with sponsors and cross-functional teams, following industry-standard processes and helping generate reliable, high-quality data. It also provides opportunities to share technical expertise, guide project teams, and contribute to standards and continuous improvement.

Requirements

• Bachelor's degree in life sciences, computer science, health informatics, clinical research, or a related discipline.
• Proven experience with eCOA, ePRO, or eDiary.
• Strong clinical research industry experience within a CRO or pharmaceutical setting.
• Experience with EDC systems and an 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 other applicable local and international regulatory requirements.
• Experience with technical quality control, UAT, defect management, change control, and validated clinical systems.
• Experience supporting global studies, sponsors, and cross-functional project teams.
• Strong communication, organization, and problem-solving skills, including root-cause analysis, risk identification, and decision-making in ambiguous situations.
• Proficient presentation and system-demonstration skills.
• Written and oral fluency in English.

Nice To Haves

• Hands-on experience configuring an eCOA platform such as Medidata Designer eCOA, or comparable study-design technology.
• Experience with Medidata Rave EDC.

Responsibilities

• Design, set up, maintain, revise, and close out eCOA studies by interpreting protocols, schedules of assessments, eCOA specifications, and licensed instrument requirements.
• Configure questionnaires, screens, field properties, code lists, schedules, branching logic, rules, reminders, alerts, notifications, and study settings in the approved eCOA platform, applying established naming conventions and build standards.
• Coordinate initial eCOA configuration and its controlled push to EDC, maintaining alignment among the eCOA configuration, EDC draft, and applicable CRF versions.
• Assess and implement approved protocol amendments, production revisions, translations, and study maintenance changes while protecting data integrity and traceability.
• Perform technical quality control of eCOA configurations against approved specifications and support User Acceptance Testing (UAT), including test evidence, defect triage, and resolution.
• Coordinate deployment readiness and support post-production troubleshooting and controlled implementation of approved corrections.
• Collaborate with Clinical Database Programming, Data Management, eCOA Clinical Data Analysis, COA Science, and Clinical Operations to finalize eCOA requirements and resolve design issues.
• Lead or participate in design and build meetings, communicate configuration status, identify risks and dependencies, and manage scope, timeline, and resourcing changes across multiple projects.
• Serve as a technical contact for sponsors and vendors on eCOA design, specification, testing, and deployment topics, as assigned.
• Create and maintain eCOA specifications, configuration records, test evidence, and other study artifacts in accordance with SOPs, Work Instructions, ICH-GCP, and applicable regulatory requirements.
• Provide role-relevant training, coaching, and technical guidance to project teams and less-experienced study designers.
• Contribute to standards, reusable libraries, and continuous improvement.

Benefits

• Health, vision, and dental insurance.
• Tuition reimbursement.
• Vacation, holiday, and sick time.
• Flexible Spending and Health Savings Accounts.
• Work/life balance.
• 401(k) with company match.
• Pet insurance.
• Life insurance.
• Some roles may be eligible for additional incentives, bonuses, or other compensation programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior