Principal Clinical Database Programmer – eCOA
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Job Description
Principal eCOA Database Programmer configuring compliant clinical-trial questionnaires and workflows for Parexel. Supporting EDC integration, validation, deployment, and global study teams.
Responsibilities:
- Interpret protocols, schedules of assessments, eCOA specifications and licensed instrument requirements to design electronic data collection workflows
- Configure questionnaires, screens, field properties, code lists, schedules, activities, completion settings, branching logic, rules, reminders, alerts, notifications and study settings in the approved eCOA platform
- Coordinate initial eCOA configuration and controlled push to EDC
- Maintain alignment among eCOA configuration, EDC draft and applicable CRF versions
- Implement approved protocol amendments, production revisions, translations and study maintenance changes
- Perform technical quality control of eCOA configurations against approved specifications
- Prepare system demonstrations, test evidence, questionnaire screenshots and UAT materials
- Support pre-UAT meetings, UAT execution, defect triage and resolution
- Coordinate deployment readiness and communicate technical quality control and UAT prerequisite completion
- Support post-production troubleshooting and controlled implementation of corrections
- Collaborate with Clinical Database Programming, Data Management, eCOA Clinical Data Analysis, COA Science, Clinical Operations and other study functions
- Lead or participate in design and build meetings, provide configuration status, identify risks and dependencies, and escalate issues
- Interact with sponsors and vendors as a technical contact for eCOA design, specification, testing and deployment
- Provide input to study timelines and monitor assigned work, scope, assumptions and resourcing needs
- Provide technical advice to internal project teams across multiple projects
- Create and maintain eCOA specifications, configuration records, implementation checklists, test evidence, screenshots, issue records and version documentation
- Maintain study documentation according to SOPs, Work Instructions and guidelines
- Document deviations, decisions, risks and configuration limitations
- Follow system life cycle, access control, change control, validation and records-management requirements
- Provide technical solutions for eCOA study design and interaction with EDC and other clinical systems
- Develop and maintain standards, reusable libraries, templates, checklists, tools and processes
- Identify recurring defects or process gaps, contribute to root-cause analysis and corrective or preventive improvements
- Provide training, coaching and technical guidance to project teams and less-experienced study designers
- Assist teams with complex configuration, workflow and integration issues
- Provide technical input to proposals, assumptions, effort estimates, client presentations and bid-defense meetings
Requirements:
- Bachelor's degree in life sciences, computer science, health informatics, clinical research or a related discipline
- Written and oral fluency in English
- Proven experience with eCOA, ePRO, eDiary is required
- Strong clinical research industry experience (CRO/Pharma) is required
- Hands-on experience configuring an eCOA platform such as Medidata Designer eCOA, or comparable study-design technology, is preferred
- Knowledge of questionnaire design, schedules, branching logic, reminders, notifications, translations, version management, and participant workflows
- Experience with EDC systems, preferably Medidata Rave, and understanding of eCOA-to-EDC configuration dependencies and data flow
- 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 ability to collaborate with global, cross-functional teams and work independently across multiple time zones and cultures
- Excellent communication skills, including the ability to explain technical design decisions to technical and non-technical audiences
- Ability to interpret clinical protocols, schedules of assessments, questionnaires and technical specifications and translate them into system configurations
- Proven problem-solving skills, including root-cause analysis, risk identification and decision-making in ambiguous situations
- Customer focus and the ability to interact professionally with sponsors, vendors and internal colleagues
- Proficient presentation and system-demonstration skills
Benefits:
- Fully home-based opportunity
- Full-time employment
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