Senior Clinical Database Programmer – eCOA

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Develop, establish, oversee, modify, and conclude eCOA studies by analyzing protocols, assessment schedules, eCOA specifications, and requirements for licensed instruments.

• Set up questionnaires, screens, field properties, code lists, schedules, branching logic, rules, reminders, alerts, notifications, and study configurations within the authorized eCOA platform.

• Manage the initial eCOA configuration and its controlled integration with EDC, ensuring consistency among the eCOA setup, EDC draft, and relevant CRF versions.

• Evaluate and execute sanctioned protocol amendments, production updates, translations, and changes related to study maintenance while ensuring data integrity and traceability.

• Conduct technical quality assurance of eCOA configurations and facilitate User Acceptance Testing, which includes test documentation, defect triage, and resolution.

• Oversee deployment readiness and assist with post-production troubleshooting and the controlled application of approved corrections.

• Collaborate with Clinical Database Programming, Data Management, eCOA Clinical Data Analysis, COA Science, and Clinical Operations teams.

• Lead or take part in design and build meetings, convey configuration updates, identify risks and dependencies, and manage scope, timelines, and resource adjustments across various projects.

• Act as a technical liaison for sponsors and vendors regarding eCOA design, specifications, testing, and deployment discussions.

• Create and sustain eCOA specifications, configuration records, test documentation, and other study materials in compliance with SOPs, Work Instructions, ICH-GCP, and relevant regulatory standards.

• Offer role-specific training, mentorship, and technical support to project teams and junior study designers.

• Contribute to the development of standards, reusable libraries, and ongoing enhancement initiatives.

⛳️ Requirements

• A Bachelor's degree in life sciences, computer science, health informatics, clinical research, or a related field.

• Demonstrated experience with eCOA, ePRO, or eDiary systems.

• Strong background in the clinical research industry, preferably within a CRO or pharmaceutical environment.

• Familiarity with EDC systems and a comprehension of eCOA-to-EDC configuration interdependencies and data flow.

• Understanding of questionnaire design, schedules, branching logic, reminders, notifications, translations, version control, and participant workflows.

• Knowledge of SOPs, Work Instructions, system life-cycle methodologies, ICH-GCP, 21 CFR Part 11, and other relevant local and international regulatory guidelines.

• Experience in technical quality assurance, UAT, defect management, change control, and validated clinical systems.

• Experience in supporting global studies, sponsors, and cross-functional project teams.

• Excellent communication, organizational, and problem-solving abilities, including root-cause analysis, risk assessment, and decision-making in uncertain scenarios.

• Proficient in presentation and system demonstration skills.

• Fluency in written and spoken English.

• Practical experience in configuring an eCOA platform such as Medidata Designer eCOA, or similar study-design technologies.

• Experience with Medidata Rave EDC.

🏝️ Benefits

• Health, Vision & Dental Insurance.

• Tuition Reimbursement.

• Vacation/Holiday/Sick Time.

• Flexible Spending & Health Savings Accounts.

• Work/Life Balance.

• 401(k) with Company match.

• Pet Insurance.

• Paid time off.

• Life insurance.

• Additional benefit offerings in accordance with the terms of applicable plans.