Principal Clinical Database Programmer – eCOA

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Analyze protocols, assessment schedules, eCOA specifications, and requirements for licensed instruments to create workflows for electronic data collection.

• Set up questionnaires, screens, field properties, code lists, schedules, activities, completion settings, branching logic, rules, reminders, alerts, notifications, and study configurations in the designated eCOA platform.

• Oversee initial eCOA configuration and manage the controlled transfer to EDC.

• Ensure consistency among eCOA configurations, EDC drafts, and relevant CRF versions.

• Execute approved protocol modifications, production updates, translations, and maintenance changes for studies.

• Conduct technical quality checks of eCOA configurations to ensure compliance with approved specifications.

• Prepare system demonstrations, testing evidence, screenshots of questionnaires, and materials for UAT.

• Assist with pre-UAT meetings, execute UAT, and handle defect triage and resolution.

• Manage deployment readiness and relay information regarding technical quality control and UAT prerequisite completion.

• Aid in post-production troubleshooting and the controlled implementation of necessary corrections.

• Collaborate with Clinical Database Programming, Data Management, eCOA Clinical Data Analysis, COA Science, Clinical Operations, and other study functions.

• Lead or engage in design and build meetings, provide updates on configuration status, identify risks and dependencies, and escalate issues as needed.

• Act as a technical liaison with sponsors and vendors concerning eCOA design, specifications, testing, and deployment.

• Contribute to study timelines and oversee assigned tasks, scope, assumptions, and resource requirements.

• Offer technical advice to internal project teams across various projects.

• Develop and maintain eCOA specifications, configuration records, implementation checklists, testing evidence, screenshots, issue logs, and version documentation.

• Ensure study documentation adheres to SOPs, Work Instructions, and guidelines.

• Record deviations, decisions, risks, and configuration limitations.

• Adhere to system life cycle, access control, change control, validation, and records management protocols.

• Provide technical solutions for eCOA study design and its interaction with EDC and other clinical systems.

• Create and refine standards, reusable libraries, templates, checklists, tools, and processes.

• Identify recurring defects or process gaps and contribute to root-cause analysis, as well as corrective or preventive measures.

• Deliver training, coaching, and technical support to project teams and less-experienced study designers.

• Assist teams with intricate configuration, workflow, and integration challenges.

• Offer technical insights for proposals, assumptions, effort estimates, client presentations, and bid-defense meetings.

⛳️ Requirements

• A bachelor's degree in life sciences, computer science, health informatics, clinical research, or a related field.

• Proficiency in written and spoken English.

• Demonstrated experience with eCOA, ePRO, and eDiary is essential.

• Strong background in the clinical research industry (CRO/Pharma) is necessary.

• Preferred hands-on experience configuring an eCOA platform like Medidata Designer eCOA or similar study-design technology.

• Familiarity with questionnaire design, schedules, branching logic, reminders, notifications, translations, version management, and participant workflows.

• Experience with EDC systems, particularly Medidata Rave, along with an 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 relevant local and international regulatory standards.

• Experience in technical quality control, UAT, defect management, change control, and validated clinical systems.

• Background in supporting global studies, sponsors, and cross-functional project teams.

• Strong ability to work collaboratively with global, cross-functional teams and independently across various time zones and cultures.

• Excellent communication skills, including the capacity to convey technical design decisions to both technical and non-technical audiences.

• Ability to interpret clinical protocols, assessment schedules, questionnaires, and technical specifications, and translate them into system configurations.

• Proven problem-solving abilities, including conducting root-cause analysis, identifying risks, and making decisions in uncertain circumstances.

• Customer-oriented approach with the ability to interact professionally with sponsors, vendors, and internal colleagues.

• Proficient in presentation and system demonstration skills.

🏝️ Benefits

• Fully remote work opportunity.

• Full-time employment.