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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.
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.)