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.
Role Description:
The Senior Manager, Database Design provides program-level leadership for clinical database design activities across multiple studies and therapeutic area portfolios. The role serves as the operational database design leader across assigned portfolios and is responsible for database design strategy execution, resource management, governance, quality oversight, standardization, and modernization initiatives while ensuring delivery of compliant, validated, interoperable, analytics-ready, and inspection-ready database solutions.
Roles & Responsibilities:
- Lead execution of database design strategy across multiple studies and programs.
- Lead, coach, and develop direct reports through performance management and succession planning.
- Drive workforce planning and resource allocation across programs.
- Ensure adoption of standardized CRF design, edit checks, workflows, and metadata-driven design practices.
- Provide oversight of database build activities in Vault CDMS, Medidata Rave, and related EDC systems.
- Lead governance processes and resolve complex database design issues.
- Partner with cross-functional stakeholders and vendors to ensure seamless integration of CRF and non-CRF data.
- Drive implementation of automation, AI-enabled validation, and metadata-driven design initiatives.
- Monitor database delivery metrics, validation status, UAT outcomes, and study readiness.
- Ensure compliance with GCP, SOPs, validation standards, and regulatory expectations.
- Lead continuous improvement initiatives focused on quality, efficiency, and scalability.
- Operationalize governance processes and participate in cross-functional decision-making forums to resolve complex study and program-level database design issues.
- Ensure database configurations align with protocol requirements, CDISC/SDTM standards, downstream analytics requirements, and enterprise data strategy.
- Support resource forecasting, workload prioritization, and operational planning across database design activities.
- Mentor and develop Senior Clinical Database Designers and Clinical Database Designers while establishing performance expectations and development plans.
Accountabilities:
- Provides program-level leadership and accountability for database design delivery across multiple studies and programs, ensuring consistent, scalable, inspection-ready clinical database solutions.
- Leads and mentors database design teams, driving standardization, quality, innovation, and operational excellence across the portfolio.
- Accountable for building and maintaining a high-performing database design organization through coaching, engagement, and talent development.
- Serves as the operational database design leader across assigned portfolios, contributing to enterprise standards, governance discussions, and modernization initiatives.
- Ensures delivery of compliant, validated, interoperable, and analytics-ready databases aligned with organizational and regulatory expectations.
- Drives operational efficiencies through automation, reusable standards, and metadata-driven design methodologies.
- Approve database standards, reusable libraries, and governance processes.
- Allocate and direct database design resources across studies and programs.
- Approve talent development plans, performance objectives, and workforce allocation decisions.
- Escalate and resolve program-level database design risks and operational issues.
- Approve database design performance expectations and operational priorities.
- Drive modernization initiatives and implementation of automation strategies.
Basic Qualifications and Experience:
- Doctorate degree and 8 years of relevant experience; OR
- Master’s degree and 10 years of relevant experience; OR
- Bachelor’s degree and 12 years of relevant experience.
- Minimum 3 years of people leadership or resource management experience.
- Experience with Vault CDMS, Medidata Rave, or similar EDC platforms.
Preferred Experience:
- 13+ years of clinical research, clinical data management, or database design experience.
- Strong expertise in metadata-driven database design and clinical data architecture.
- Experience leading global database design delivery across complex portfolios.
- Strong understanding of CDISC, SDTM, RBQM, and clinical data standards.
- Experience managing external vendors and global delivery models.
- Demonstrated experience driving modernization, automation, and digital transformation initiatives.
- Experience supporting inspection readiness and regulatory audits.
Functional Competencies:
- Operational leadership and execution excellence in clinical database design and portfolio delivery.
- Strong understanding of database lifecycle management, validation, and governance processes.
- Ability to drive enterprise-level standardization and operational scalability.
- Expertise in metadata-driven design, interoperability, and analytics-ready data solutions.
- Strong risk identification, escalation, and mitigation capabilities.
- Executive communication and stakeholder management skills.
- Ability to lead organizational changes, innovation, and continuous improvement initiatives.
- Strong people leadership, mentoring, and talent development capabilities.
- Strong execution orientation combined with strategic thinking.
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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