Note: The job is a remote job and is open to candidates in USA. Parexel is hiring a Senior Clinical Database Programmer - eCOA to design, configure, test, deploy, and maintain eCOA solutions for clinical trials. The role translates protocols and instrument requirements into compliant study workflows, supports eCOA-to-EDC integration, and collaborates with sponsors and cross-functional teams through study closeout.
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 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 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, and contribute to standards, reusable libraries, and continuous improvement
Skills
- Strengths in questionnaire design, eCOA study configuration, and technical quality control
- Experience working in clinical research, healthcare, or a regulated environment
- The ability to collaborate across global, cross-functional teams and communicate technical design decisions clearly to technical and non-technical audiences
- A patient-focused mindset and strong attention to detail
- Comfort working with eCOA platforms such as Medidata Designer eCOA, EDC systems such as Medidata Rave, and validated clinical systems
- 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
Company Overview
Company H1B Sponsorship