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Parexel

Senior Clinical Database Programmer – eCOA

Parexel

. Design, set up, maintain, revise, and close out eCOA studies by interpreting protocols, schedules of assessments, eCOA specifications, and licensed instrument requirements .

Posted 10/27/2026full-timeRemote • North Carolina • United StatesSenior💰 $110,000 - $140,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in eCOA study design, configuration, and maintenance, ensuring compliance with regulatory standards such as ICH-GCP and 21 CFR Part 11. Proficient in coordinating cross-functional teams and managing project timelines while maintaining data integrity and quality control.

Highest-signal resume keywords
ECOA ConfigurationClinical Research ExperienceEDC Systems KnowledgeTechnical Quality ControlRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
ECOAEPROQuestionnaire DesignChange ControlDefect ManagementUser Acceptance TestingData IntegrityVersion ManagementRoot-Cause AnalysisRisk Identification
Soft Skills
Strong CommunicationOrganizationProblem-SolvingDecision-MakingPresentation Skills
Tools & Technologies
Medidata Designer eCOAMedidata Rave EDC
Industry Keywords
Clinical OperationsCROSOPsWork InstructionsGlobal StudiesCross-Functional TeamsStudy ArtifactsClinical Data AnalysisParticipant WorkflowsStudy Maintenance

About the role

Key responsibilities & impact
  • Design, set up, maintain, revise, and close out eCOA studies by interpreting protocols, schedules of assessments, eCOA specifications, and licensed instrument requirements
  • Configure questionnaires, screens, field properties, code lists, schedules, branching logic, rules, reminders, alerts, notifications, and study settings in the approved eCOA platform
  • Coordinate the initial eCOA configuration and controlled push to EDC, maintaining 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 and support User Acceptance Testing, including test evidence, defect triage, and resolution
  • Coordinate deployment readiness and support post-production troubleshooting and controlled implementation of approved corrections
  • Collaborate with Clinical Database Programming, Data Management, eCOA Clinical Data Analysis, COA Science, and Clinical Operations
  • Lead or participate in design and build meetings, communicate configuration status, identify risks and dependencies, and manage scope, timeline, and resourcing changes across multiple projects
  • Serve as a technical contact for sponsors and vendors on eCOA design, specification, testing, and deployment topics
  • Create and maintain eCOA specifications, configuration records, test evidence, and other study artifacts in accordance with SOPs, Work Instructions, ICH-GCP, and applicable regulatory requirements
  • Provide role-relevant training, coaching, and technical guidance to project teams and less-experienced study designers
  • Contribute to standards, reusable libraries, and continuous improvement

Requirements

What you’ll need
  • Bachelor's degree in life sciences, computer science, health informatics, clinical research, or a related discipline
  • Proven experience with eCOA, ePRO, or eDiary
  • Strong clinical research industry experience within a CRO or pharmaceutical setting
  • Experience with EDC systems and an understanding of eCOA-to-EDC configuration dependencies and data flow
  • Knowledge of questionnaire design, schedules, branching logic, reminders, notifications, translations, version management, and participant workflows
  • 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 communication, organization, and problem-solving skills, including root-cause analysis, risk identification, and decision-making in ambiguous situations
  • Proficient presentation and system-demonstration skills
  • Written and oral fluency in English
  • Hands-on experience configuring an eCOA platform such as Medidata Designer eCOA, or comparable study-design technology
  • Experience with Medidata Rave EDC

Benefits

Comp & perks
  • Health, Vision & Dental Insurance
  • Tuition Reimbursement
  • Vacation/Holiday/Sick Time
  • Flexible Spending & Health Savings Accounts
  • Work/Life Balance
  • 401(k) with Company match
  • Pet Insurance
  • Paid time off
  • Life insurance
  • Additional benefit offerings in accordance with the terms of applicable plans