Senior Clinical Database Programmer - eCOA
Parexel
Summary
We are seeking a Principal Database Programmer (eCOA Study Builder / Designer) specializing in electronic Clinical Outcome Assessment (eCOA) solutions to join our team in a remote capacity, based in any location in the continental US. You will provide technical expertise for the design, configuration, testing, deployment, and maintenance of eCOA solutions used in clinical trials. You will translate protocols, assessment schedules, and licensed instrument requirements into compliant participant, caregiver, and clinician facing questionnaires, schedules, and workflows.
Job description
About the Role
We are seeking a Principal Database Programmer (eCOA Study Builder / Designer) specializing in electronic Clinical Outcome Assessment (eCOA) solutions to join our team in a remote capacity, based in any location in the continental US. You will provide technical expertise for the design, configuration, testing, deployment, and maintenance of eCOA solutions used in clinical trials. You will translate protocols, assessment schedules, and licensed instrument requirements into compliant participant, caregiver, and clinician facing questionnaires, schedules, and workflows.
Key Responsibilities
- 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 against approved specifications and support User Acceptance Testing (UAT)
- 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 to finalize eCOA requirements and resolve design issues
- 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
Candidate Profile
- Strengths in questionnaire design, eCOA study configuration, and technical quality control
- Experience working in clinical research, healthcare, or a regulated environment
- Ability to collaborate across global, cross-functional teams and communicate technical design decisions clearly
- Patient-focused mindset and strong attention to detail
- Comfort working with eCOA platforms such as Medidata Designer eCOA, EDC systems such as Medidata Rave, and validated clinical systems
Requirements
- 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 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 applicable 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 and risk identification
- Proficient presentation and system-demonstration skills
- Written and oral fluency in English
- Preferred: Hands-on experience configuring an eCOA platform such as Medidata Designer eCOA or comparable study-design technology
- Preferred: Experience with Medidata Rave EDC
Benefits
- 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
- Life Insurance
Company overview
Parexel is one of the world's largest and most prominent contract research organizations (CROs), providing comprehensive clinical research services to pharmaceutical and biotechnology companies globally. Founded in 1982 and headquartered in Raleigh, North Carolina, Parexel operates with a global workforce of over 24,000 professionals across 84+ facilities in 49 countries. The company specializes in managing the full spectrum of clinical trials from Phase I to IV across diverse therapeutic areas including neuroscience, oncology, infectious diseases, hematology, and general medicine. Parexel offers end-to-end solutions encompassing clinical trial management, regulatory strategy, data management, biostatistics, pharmacovigilance, medical communications, and market access consulting. With a strong track record spanning over 40 years, Parexel has established itself as a trusted partner for both established pharmaceutical leaders and emerging biotech innovators, helping accelerate drug development and bring life-saving treatments to patients faster through its patient-centric approach and operational excellence.