Biomedical Data Stewardship Manager

Amgen • Thousand Oaks, CA

173d • Remote

About The Position

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas - Oncology, Inflammation, General Medicine, and Rare Disease - we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Requirements

• Doctorate degree or Master's degree and 2 years of clinical experience or Bachelor's degree and 4 years of clinical experience or Associate's degree and 8 years of clinical experience or High school diploma / GED and 10 years of clinical experience.

Nice To Haves

• Degree in a related field such as statistics, biostatistics, life sciences, programming, computer science, or business administration.
• 5+ years cumulative experience in data management, biostatistics, or clinical programming within the pharmaceutical or biotechnology industry.
• 3+ years of experience in a global, matrixed organization.
• Proven experience with CRF design, data standards governance, and clinical metadata repository (MDR) tools.
• Experience in data collection, analysis, and reporting within drug development and clinical trial processes.

Responsibilities

• Drive the design, implementation, and governance of standardized data collection practices across clinical programs.
• Build and manage case report form (CRF) libraries and develop implementation standards.
• Partner closely with cross-functional teams to ensure high-quality data collection that supports drug development success.
• Lead standards implementation for study teams through hypercare sessions.
• Monitor and review use of standards and facilitate governance processes.
• Design and define standard, indication-level CRF libraries using global standards-based and study-specific content.
• Design and review clinical data quality edit checks aligned with CRF content.
• Provide expert consultation and hypercare support to study teams in applying CRF library content and related tools.
• Monitor adoption and consistency of CRF standards, conducting audits and reviews to ensure alignment with evolving study and regulatory needs.
• Manage governance processes for evaluating and implementing updates or exceptions to CRF standards.
• Coordinate with global standards governance bodies to ensure harmonized updates and compliant implementation across programs.
• Curate and manage standards content within a metadata repository (MDR), ensuring traceability, reusability, and consistency.
• Lead initiatives to expand data standards implementation across Amgen's Global Development functions and external collaborations.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Master's degree