About this role
About the Role The Senior Database Designer at Amgen translates study protocol requirements into compliant, scalable database configurations within Vault CDMS, Medidata Rave, or similar EDC platforms. This role leads end-to-end database build activities while ensuring alignment with organizational standards, quality expectations, and regulatory requirements in a global cross-functional environment. What You'll Do
- Translate study protocol requirements into compliant and efficient database configurations within Vault CDMS and/or Medidata Rave.
- Lead end-to-end database build activities including forms, edit checks, workflows, integrations, and configuration updates.
- Drive metadata-driven clinical data design with a focus on automation, scalability, and standardization.
- Enable interoperable and analytics-ready data solutions by incorporating downstream data consumption considerations.
- Participate in design review sessions and implement approved database enhancements and changes.
- Coordinate study go-live readiness activities to support delivery within established timelines and quality expectations.
- Implement metadata-driven database design methodologies aligned with organizational standards and best practices.
- Partner with study teams to ensure database configurations align with CDISC/SDTM standards and study requirements.
- Contribute to RBQM-aligned data review, discrepancy identification, and risk mitigation activities.
- Execute, document, and coordinate UAT activities, ensuring timely escalation and resolution of identified issues.
- Design database configurations that support efficient site workflows, optimized usability, and reduced operational complexity.
- Troubleshoot and resolve issues related to edit checks, data flow, integrations, and database functionality.
- Maintain complete, accurate, and audit-ready build documentation, testing evidence, and validation.