Principal Clinical Database Programmer - eCOA

Parexel as a Principal Database Programmer – eCOA (eCOA Study Designer) , a fully home-based opportunity open to candidates across the UK!

About Parexel

• When our values align, there's no limit to what we can achieve.
• At Parexel, we all share the same goal - to improve the world's health.
• From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
• Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient.
• We take our work personally, we do it with empathy and we're committed to making a difference.

Responsibilities

• The eCOA Study Designer works independently across multiple projects, collaborates with sponsors and cross-functional study teams, and supports integration of eCOA configurations with Electronic Data Capture (EDC) systems.
• Design, Set Up, Maintain, Revise and Close Out eCOA Studies: Interpret protocols, schedules of assessments, eCOA specifications and licensed instrument requirements to design appropriate 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.
• Apply established naming conventions and build standards, including clear identification of eCOA-specific forms, fields and code lists.
• Coordinate the initial eCOA configuration and controlled push to EDC; maintain 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, including screens, questionnaire workflows, rules, notifications and schedules.
• Prepare system demonstrations, test evidence, questionnaire screenshots and other materials required for internal review and User Acceptance Testing (UAT).
• Support pre-UAT meetings, UAT execution, defect triage and resolution; ensure issues are documented in the approved study issue-tracking process.
• Coordinate deployment readiness and communicate completion of technical quality control and UAT prerequisites to applicable stakeholders.
• Support post-production troubleshooting and controlled implementation of approved corrections.
• Collaborate with Clinical Database Programming, Data Management, eCOA Clinical Data Analysis, COA Science, Clinical Operations, and other study functions to finalize eCOA requirements and resolve design issues.
• Lead or participate in recurring design and build meetings, provide configuration status, identify risks and dependencies, and escalate issues when required.
• Interact with sponsors and vendors as a technical contact for eCOA design, specification, testing and deployment topics, as assigned.
• Provide input to study timelines, monitor assigned work and communicate changes in scope, assumptions or resourcing needs.
• Provide technical advice to internal project teams and support multiple projects simultaneously.
• Create and maintain eCOA specifications, configuration records, implementation checklists, test evidence, screenshots, issue records, version documentation, and other required study artifacts.
• Maintain study documentation in accordance with SOPs, Work Instructions, and guidelines to support traceability, inspection readiness, and regulatory compliance.
• Document deviations, decisions, risks, and configuration limitations and communicate them to the appropriate project stakeholders.
• Follow system life cycle, access control, change control, validation and records-management requirements.
• Provide technical solutions to internal and external client inquiries relating to eCOA study design and its interaction with EDC and other clinical systems.
• Participate in the development and maintenance of standards, reusable libraries, templates, checklists, tools and processes that improve eCOA delivery quality and efficiency.
• Identify recurring defects or process gaps, contribute to root-cause analysis and support implementation of corrective or preventive improvements.
• Act as a Trainer and/or Subject Matter Expert: Provide role-relevant training, coaching, and technical guidance to project teams and less-experienced study designers, as appropriate.
• Assist project teams in resolving complex configuration, workflow, and integration issues.
• Provide technical input to proposals, assumptions, effort estimates, client presentations, and bid-defense meetings, as requested.

Requirements

• The Principal Database Programmer – eCOA (eCOA Study Designer) provides technical expertise for the design, configuration, testing, deployment and maintenance of electronic Clinical Outcome Assessment (eCOA) solutions used in clinical trials.
• The role translates protocol, assessment and operational requirements into compliant participant, caregiver and clinician facing questionnaires, schedules and workflows within approved eCOA technologies.
• 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.
• 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.

Preferred

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