About the Role
We are seeking a Clinical Database Programmer I to support the configuration, testing, and maintenance of clinical study databases. In this role, you will help translate approved study requirements into reliable electronic data capture solutions that support high-quality clinical data and compliant study delivery.
You will work closely with Data Management, Clinical Operations, study teams, and external partners throughout the clinical trial lifecycle.
What You'll Do
- Configure clinical study databases using an EDC platform such as Medidata Rave.
- Build and test edit checks, calculations, derivations, conditional logic, and dynamic forms.
- Create and maintain study forms, fields, folders, matrices, dictionaries, and related database components.
- Perform database testing, validation, and user acceptance testing.
- Document test results, defects, resolutions, and database releases.
- Support the setup and reconciliation of external data feeds, including laboratory, ECG, imaging, and ePRO data.
- Implement approved database changes, amendments, and migration activities.
- Build and test reports and listings used for clinical data review.
- Maintain configuration, version-control, and audit-readiness documentation.
- Work with project teams to track deliverables, identify risks, and elevate issues affecting timelines or data integrity.
- Support data mapping, system integration, and audit activities as required.
Must-Have Skills and Experience
- Bachelor's degree in computer science, life sciences, health sciences, mathematics, statistics, or a related field.
- At least 1 year of experience in clinical database programming, EDC configuration, clinical data management systems, or a related area.
- Experience using an EDC or clinical database platform; Medidata Rave experience is preferred.
- Understanding of clinical trial data, CRF/eCRF design, database testing, and data validation.
- Familiarity with CDISC CDASH principles.
- Working knowledge of ICH GCP and computerized system compliance requirements, including 21 CFR Part 11.
- Strong attention to detail and commitment to data quality.
- Ability to interpret specifications and accurately configure system functionality.
- Strong organizational, written, and verbal communication skills.
- Ability to work collaboratively and deliver assigned activities within agreed timelines.
Nice-to-Have Skills and Experience
- Experience with Medidata Rave edit checks, derivations, dynamic forms, or custom functions.
- Exposure to CDISC SDTM, controlled terminology, or broader clinical data standards.
- Experience supporting external data transfers and reconciliation.
- Familiarity with laboratory, ECG, imaging, ePRO, wearable, or other non-CRF data.
- Experience with database amendments, migrations, production releases, or system upgrades.
- Knowledge of computerized system validation, traceability, change control, and issue management.
- Experience creating clinical data review reports, listings, or dashboards.
- Previous experience in a pharmaceutical, biotechnology, medical device, or CRO environment.
- Training or certification in clinical data management, EDC configuration, GCP, or system validation.