Principal Clinical Database Programmer - eCOA
Fully remote (UK) role at CRO Parexel: a principal-level eCOA Study Designer who configures, tests, deploys and maintains electronic Clinical Outcome Assessment studies for clinical trials, translating protocols into questionnaires, schedules and workflows (e.g. Medidata Designer eCOA) and integrating them with EDC systems like Medidata Rave.
- Compensation
- Not disclosed
- Location
- United Kingdom-Sheffield-Remote
- Work setup
- Remote
- Seniority
- Principal
- Employment
- Not specified
- Experience
- Not specified
- Category
- Not specified
- Posted
Skills
Must have
- Bachelor's degree in life sciences, computer science, health informatics, clinical research or related discipline
- Written and oral fluency in English
- Proven experience with eCOA, ePRO, eDiary
- Strong clinical research industry experience (CRO/Pharma)
- Knowledge of questionnaire design, schedules, branching logic, reminders, notifications, translations, version management and participant workflows
- Experience with EDC systems 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 regulations
- Experience with technical quality control, UAT, defect management, change control and validated clinical systems
- Experience supporting global studies, sponsors and cross-functional project teams
- Ability to collaborate with global, cross-functional teams and work independently across multiple time zones and cultures
- Excellent communication skills, able to explain technical design decisions to technical and non-technical audiences
- Ability to interpret clinical protocols, schedules of assessments, questionnaires and technical specifications into system configurations
- Proven problem-solving skills, including root-cause analysis, risk identification and decision-making in ambiguous situations
- Customer focus and professional interaction with sponsors, vendors and internal colleagues
- Proficient presentation and system-demonstration skills
Nice to have
- Hands-on experience configuring an eCOA platform such as Medidata Designer eCOA or comparable study-design technology
- Experience with Medidata Rave EDC
Full description
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.
Join Parexel as a Principal Database Programmer – eCOA (eCOA Study Designer), a fully home-based opportunity open to candidates across the UK!
Picture Yourself at Parexel:
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. 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.
What You'll Do At Parexel: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.
Testing, Validation and Deployment:
- 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.