Remote Principal eCOA Study Designer

Parexel; United States; Remote; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is a leading global clinical development partner seeking a Principal Database Programmer (eCOA Study Builder/Designer) to join our remote team in the continental US. You will design, configure, test, and maintain eCOA studies and ensure integration with EDC systems for high-quality data.

You will translate protocols into participant, caregiver, and clinician questionnaires, support QA/UAT, and collaborate with sponsors and cross-functional teams while upholding regulatory standards and

Qualifications

• 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 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 11, and other 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.
• Proficient presentation and system-demonstration skills.
• Written and oral fluency in English

Responsibilities

• Design, set up, maintain, revise, and close out eCOA studies by interpreting protocols and instrument requirements.
• Configure questionnaires, screens, field properties, code lists, schedules, branching logic, reminders, and study settings.
• Coordinate initial eCOA configuration and push to EDC, maintaining alignment with CRF versions.
• Assess and implement protocol amendments, production revisions, translations, and study maintenance changes.
• Perform technical quality control of eCOA configurations and support UAT with test evidence.
• Coordinate deployment readiness and post-production troubleshooting.
• Collaborate with Clinical DB Programming, Data Management, eCOA CDAnalysis, COA Science & Clinical Ops to finalize requirements.
• Lead or participate in design/build meetings, communicate status, manage risks and scope across projects.
• Serve as technical contact for sponsors and vendors on eCOA topics.
• Create and maintain eCOA specs, configuration records, test evidence per SOPs and regulatory requirements.
• Provide training and guidance to project teams and contribute to standards and reusable libraries.

Skills

Questionnaire design

eCOA configuration

Technical quality control

Clinical research experience

Cross-functional collaboration

English communication

Medidata Designer eCOA

Medidata Rave

Education

Bachelor’s degree in life sciences, computer science, health informatics, clinical research, or related discipline

Tools

Medidata Designer eCOA

Medidata Rave EDC

Job description

Parexel is a leading global clinical development partner seeking a Principal Database Programmer (eCOA Study Builder/Designer) to join our remote team in the continental US. You will design, configure, test, and maintain eCOA studies and ensure integration with EDC systems for high-quality data.

You will translate protocols into participant, caregiver, and clinician questionnaires, support QA/UAT, and collaborate with sponsors and cross-functional teams while upholding regulatory standards and