Career Category
Clinical Development
Job Description
Join Amgen’s Mission of Serving Patients
ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
ABOUT THE ROLE
Role Description:
The Senior Database Designer is responsible for translating study protocol requirements into compliant, scalable, and efficient database configurations within Vault CDMS, Medidata Rave, or similar EDC platforms. This role leads end-to-end database build activities including CRF design, edit checks, workflows, integrations, and validation activities while ensuring alignment with organizational standards, quality expectations, and regulatory requirements.
This role operates within a global cross-functional environment and collaborates with Data Delivery Leads, Biostatistics, Clinical Operations, vendors, and study teams to deliver high-quality database solutions that support clinical trial execution and downstream analytics readiness.
Roles & Responsibilities:
- 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 records.
- Collaborate with Data Acquisition Leads and cross-functional study teams to support integration of external and non-CRF data sources.
- Contribute to continuous improvement initiatives, process optimization efforts, and lessons learned activities.
Accountabilities:
- Deliver high-quality, validated EDC databases within timelines and quality expectations.
- Support mentoring activities, reusable standards development, and process harmonization initiatives.
- Support CRF design, edit checks, calculated fields, and related configurations using established standards and templates.
- Support UAT execution, troubleshooting, build documentation, and study readiness activities.
- Maintain compliance with database design standards, SOPs, and inspection readiness expectations.
Basic Qualifications and Experience:
- Bachelor’s degree in life sciences, computer science, health sciences, or related discipline and 5 years of relevant clinical database design experience in EDC systems such as Rave, Veeva, or similar platforms; OR
- Master’s degree in life sciences, computer science, health sciences, or related discipline and 4 years of relevant clinical database design experience in EDC systems such as Rave, Veeva, or similar platforms.
- Experience in clinical research, clinical data management, or EDC database design.
- Working expertise in Vault CDMS, Medidata Rave, or similar EDC platforms.
- Understanding of GCP, clinical trial workflows, and regulatory expectations.
- Experience supporting global clinical trial teams.
- Exposure to UAT execution, discrepancy resolution, and database lifecycle activities.
Preferred Experience:
- 5–7 years of experience in clinical research, clinical data management, or EDC database design.
- Experience working across global clinical trial teams and multiple geographies.
- Familiarity with CDISC and SDTM data standards.
- Experience supporting metadata-driven database design methodologies.
- Exposure to RBQM concepts and inspection readiness activities.
Functional Competencies:
- Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools.
- Familiarity with CDISC and SDTM data standards.
- Understanding of metadata-driven database design principles.
- Awareness of Risk-Based Quality Management (RBQM) concepts and data review practices.
- Knowledge of clinical data standards and regulatory compliance expectations.
- Strong organizational, analytical, and documentation skills.
- Effective communication and collaboration with cross-functional stakeholders.
- Ability to manage multiple assignments and timelines with moderate supervision.
- Strong attention to detail and focus on data quality.
- Demonstrated initiative, learning agility, and continuous improvement mindset.
- Ability to independently manage competing priorities across multiple studies.
- Ability to influence cross-functional problem solving and apply risk-based decision making.
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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