Duration: 6 Months
Experience: 8–10 Years
Work Location: Indianapolis ,In
Job Overview
We are seeking an experienced eCOA Build Programmer to design, configure, program, and test electronic Clinical Outcomes Assessment systems used in global clinical trials.
The role will focus on clinical data collection, system configuration, data mapping, validation, testing, and integration with clinical data platforms. The ideal candidate will have hands-on experience with eCOA, eDC, eSource, or Direct Data Capture implementations and strong knowledge of clinical data workflows and database technologies.
Primary Skills
- eCOA / Electronic Clinical Outcome Assessment,
- Clinical Database Programming,
- eCOA Study Build & Configuration,
- Clinical Data Management,
- Clinical Data Mapping
- Clinical Data Validation & Testing
- Clinical Trial Systems
- SQL / Database Programming
- HTML / CSS / JavaScript
Secondary Skills
- eDC / Electronic Data Capture,
- eSource / Direct Data Capture,
- Node.js,
- JSON,
- SpEL
- MongoDB
- GitLab
- Data Warehousing
- Data Analytics & Visualization
- EDC / IRT / CTMS Integrations
- Data Mapping
- Clinical Data Standards
- System Integration Testing
- UAT / Regression Testing
- GxP / Validation
- Clinical Protocol Interpretation
Key Responsibilities
- Review clinical protocols, eCOA requirements, instrument specifications, translations, visit schedules, and edit-check requirements to determine study build scope.
- Configure and program eCOA studies, including questionnaires, diaries, assessments, visit workflows, notifications, user roles, devices, and data-transfer settings.
- Translate approved clinical and business requirements into accurate system configurations.
- Maintain end-to-end traceability between requirements, configuration, testing, and deployment.
- Develop and maintain build specifications, configuration documentation, test scripts, validation evidence, release notes, and deployment records.
- Conduct unit testing and support integration, UAT, regression, and production validation activities.
- Manage defects and change requests, perform impact assessments, and troubleshoot configuration and data issues.
- Work with instrument owners and licensing teams to ensure approved content, scoring rules, copyright requirements, and language versions are implemented correctly.
- Coordinate study-build activities across distributed teams and track milestones, dependencies, risks, and issues.
- Support data integrations between eCOA platforms and clinical systems such as EDC, IRT, CTMS, data warehouses, and analytics environments.
- Ensure study builds comply with SOPs, documentation practices, validation requirements, data privacy expectations, and applicable regulations.
- Support production deployment, study go-live, post-production verification, maintenance releases, amendments, and study closeout.
- Contribute to reusable templates, standards, automation, peer reviews, and continuous improvement of eCOA build processes.
Required Qualifications
- 8–10 years of relevant clinical data / database programming experience.
- Hands-on experience with eCOA, eDC, eSource, or Direct Data Capture implementations.
- Experience designing electronic CRF or clinical data collection screens and implementing validations.
- Strong understanding of clinical protocols and clinical terminology.
- Experience with clinical data collection tools, workflows, testing, and validation.
- Strong knowledge of data structures, mapping, normalization, and data flows.
- Experience with relational and non-relational databases.
- Strong SQL and database programming experience.
- Programming experience with HTML, CSS, JavaScript, Node.js, JSON, and/or SpEL.
- Experience using GitLab or similar source-control tools.
- Strong analytical, troubleshooting, communication, and collaboration skills.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
We are committed to providing reasonable accommodations to qualified applicants with disabilities and for sincerely held religious beliefs, as required by applicable law. Applicants who require a reasonable accommodation during the hiring process may request assistance.
Employment may be contingent upon the successful completion of job-related pre-employment screening, which may include background and reference checks and, where permitted by applicable law and applicable to the position, drug testing. All such screening will be conducted in accordance with applicable federal, state, and local laws.
