Clinical Database Programmer

The Clinical Database Programmer will support the transition from paper-based data collection to electronic data capture (EDC) for clinical studies. They will build and maintain study databases, design electronic data collection forms, program edit checks to ensure data quality, create data tables and reports to be used for study reporting and statistical analysis. The role also supports the selection, introduction, and day-to-day management of key clinical systems, including EDC, electronic Trial Master File (eTMF), and Clinical Trial Management System (CTMS).

This role will include:

• Build and maintain EDC study databases and eCRFs, including programming edit checks and derivations, and managing UAT and database go-live.
• Ensure data quality by supporting data collection, cleaning, validation, and quality control, and by producing datasets, listings, and reports for review and analysis.
• Manage data transfers and integrations with external vendors, including defining data transfer specifications.
• Support implementation and maintenance of clinical systems (EDC, eTMF, CTMS), including configuration, validation documentation, and user training.
• Ensure clinical systems and processes comply with GCP, GDPR, and internal data governance requirements.
• Apply data and submission standards (e.g. CDISC / SDTM) where required.
• Work closely with clinical, statistics, and project teams and act as a key contact for database-related questions and issues.
• Maintain clear study and system documentation (e.g. Data Management Plans, validation records, SOPs, and training materials).

Other skills and experience required:

• Degree in Life Sciences, Computer Science, Data Science, or related field, or equivalent experience.
• Experience building EDC study databases and programming edit checks.
• Experience working with clinical study data, including data cleaning, validation, and reporting.
• Practical experience with at least one data or programming tool (e.g. SAS, SSPS or similar).
• Understanding of GCP, GDPR, and basic data governance principles.
• Strong attention to detail, with a structured approach to testing, documentation, and quality checks.
• Good communication and teamwork skills, comfortable working with cross-functional stakeholders.

Desirable:

• Experience planning or leading UAT and database/system go-live activities.
• Experience with computer system validation (CSV) and related documentation.
• Familiarity with CDISC standards, including SDTM, and working with standardised datasets.
• Experience with eTMF and CTMS as well as EDC.
• Experience working with external data providers and managing data transfer specifications.