[Hiring] Principal Clinical Database Programmer @Parexel

Role Description

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.
  • 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.
• Project and Stakeholder Support:
  • 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.
• Documentation and Compliance:
  • 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.
• Support Technologies, Standards and Continuous Improvement:
  • 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.
• Support Business Development:
  • Provide technical input to proposals, assumptions, effort estimates, client presentations, and bid-defense meetings, as requested.

Qualifications

• 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.