Elanco - Database Programmer - Clinical Data Management

About the Role

We are seeking a skilled and experienced Database Programmer to support global clinical data management processes for animal health R&D programs. This role focuses on the design, development, validation, and maintenance of clinical trial databases and electronic data capture (EDC) systems. The ideal candidate will have a strong background in programming, data management technologies, and clinical trial operations.

As part of the Global Clinical Data Management team, the Database Programmer will work closely with cross-functional stakeholders including data managers, biostatisticians, quality assurance professionals, and clinical scientists to ensure high-quality, compliant, and validated data systems for both preclinical and clinical trials in farm and companion animals.

Key Responsibilities :

- Develop, configure, and maintain clinical trial databases using industry-standard EDC platforms (e.g., Medrio, Veeva, Rave, Inform).

- Design and implement Case Report Forms (CRFs), edit checks, custom functions, derivations, validation rules, and other database components.

- Perform end-to-end database programming tasks: design, testing (unit/self-testing), documentation, deployment, and post-production updates.

- Leverage and customize global libraries for database components while maintaining consistency and compliance.

- Conduct impact assessments for protocol amendments and manage migrations and post-production database updates accordingly.

- Execute annotation of CRFs and maintain traceability documentation for regulatory submissions.

- Participate in User Acceptance Testing (UAT) for new system releases and functionality rollouts.

- Troubleshoot and resolve database issues in collaboration with internal and external stakeholders.

- Maintain and update user documentation, global programming libraries, and internal audit trails.

- Support coding module configurations (e.g., MedDRA, WHO Drug Dictionary) as needed.

- Ensure systems are compliant with GxP and regulatory requirements, including 21 CFR Part 11.

- Collaborate on the development and revision of SOPs, process documentation, and quality management materials.

- Act as a technical liaison between data management, clinical, IT, and external vendors.

Minimum Qualifications :

- Bachelors degree (B.S.) in Computer Science, Information Technology, Life Sciences, Statistics, or related field.

- 711 years of experience in database programming, preferably in a clinical data management or R&D setting.

- Hands-on experience with one or more EDC systems: Medrio, Rave, Inform, Veeva, etc.

- Proficiency in SQL, PL/SQL, or related database languages for querying and validation.

- Experience with version control, change management, and documentation best practices.

- Strong understanding of GCP, GxP, and regulatory standards related to clinical data systems.