Senior Clinical Database Programmer – eCOA

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $110k - $140k / year

⏰ Full Time

🟠 Senior

🖥 Software Engineer

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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 • Coordinate the initial eCOA configuration and 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 and support User Acceptance Testing, 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 • 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 • 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

🎯 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 • Hands-on experience configuring an eCOA platform such as Medidata Designer eCOA, or comparable study-design technology • 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