Principal Clinical Database Programmer – eCOA

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🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🔴 Lead

🖥 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

• 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