Clinical Informatics Executive

Data Acquisition Lead

Career Category

Clinical

Job Description

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 
In this vital role you will 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

Basic Qualifications:

• Doctorate degree OR

• Master’s degree and 8 years of clinical execution experience OR

• Bachelor’s degree and 8years of clinical execution experience OR

• Associate’s degree and 8 years of clinical execution experience

Preferred Qualifications:

• 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.)

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Experience Level

Senior Level