This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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.
Job Responsibility:
Lead the acquisition, integration, and quality management of non-CRF (external/vendor) clinical trial data, ensuring it is timely, accurate, and fit-for-purpose to support study delivery, analytics, with regulatory compliance
Own the design, setup, and ongoing management of non-CRF data (e.g., central labs, imaging, wearables, precision medicine), ensuring seamless integration and traceability
Own, define and maintain vendor data transfer specifications, oversee data transfer agreements aligned to study requirements
Ensure timely and accurate ingestion of external datasets, proactively resolving formatting, mapping, and data quality issues – own query resolution with data including issue escalation with study team and/or suppliers
Partner with other Data Management roles as well as the study team (global/local) to ensure external data aligns with CRF structures and is accessible within EDC or other data platforms for downstream processes including archival
Lead troubleshooting of vendor integration issues, including delayed or inconsistent data deliveries, missing data and escalate issues and systemic risks as needed
Monitor the quality of incoming data throughout the study lifecycle and initiate early reconciliation to prevent downstream delays – ensure we are 'data delivery/analysis' ready at all times
Requirements:
Master's degree and 8 years of clinical execution experience
Bachelor's degree and 8 years of clinical execution experience
8 years work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)