Senior Clinical Database Programmer - eCOA

Parexel•Raleigh, NC

3d•$110,000 - $140,000•Remote

About The Position

Parexel is seeking a Principal Database Programmer (eCOA Study Builder/Designer) to provide technical expertise for the design, configuration, testing, deployment, and maintenance of electronic Clinical Outcome Assessment (eCOA) solutions used in clinical trials. This remote position may be based anywhere in the continental United States. The role translates protocols, assessment schedules, and licensed instrument requirements into compliant participant-, caregiver-, and clinician-facing questionnaires, schedules, and workflows. It supports study execution, regulatory compliance, and clinical data accuracy, including configuration and testing in approved eCOA platforms and integration with Electronic Data Capture (EDC) systems. The position contributes to eCOA study delivery from design through closeout while supporting multiple projects and collaborating with sponsors and cross-functional teams. It also provides technical expertise and guidance to project teams, with opportunities to contribute to study outcomes, reusable standards, and continuous improvement.

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 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.
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 to technical and non-technical audiences.
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.

Nice To Haves

Hands-on experience configuring an eCOA platform such as Medidata Designer eCOA, or comparable study-design technology.
Experience with Medidata Rave EDC.

Responsibilities

Design, set up, maintain, revise, and close out eCOA studies by interpreting protocols, assessment schedules, eCOA specifications, and licensed instrument requirements.
Configure questionnaires, screens, field properties, code lists, schedules, branching logic, rules, reminders, alerts, notifications, and study settings in approved eCOA platforms, applying established naming conventions and build standards.
Coordinate initial eCOA configuration and its 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), 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 to finalize 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, as assigned.
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, and contribute to standards, reusable libraries, and continuous improvement.