Career Category Clinical Job Description In this vital role you are accountable for the management and oversight of data collected within a study/program, you will lead end-to-end data management and ensure high-quality, timely, and decision-ready data that enables successful clinical trial delivery. Serve as the single accountable leader for study-level data management, driving quality, delivery, and cross-functional alignment, locally and globally Lead development and execution of the Data Management Plan and Integrated Data Review Plan (IDRP) aligned to protocol and program strategy Drive database build, UAT, and go-live readiness in partnership with Database Design and Acquisition teams Oversee study conduct activities including data cleaning, query management, reconciliation, and database lock preparation, ensuring we are ‘delivery ready’ at all times Monitor study data metrics (e.g., eCRF entry, Non-CRF data collection, query aging, reconciliation backlog, KRIs) and proactively resolve issues to ensure on-time delivery Lead data deliverables, proactive in follow up, ensuring issue resolution and high-quality outputs Basic

Qualifications

Doctorate Degree OR Master’s Degree and 2 years of life science, computer sciences, business administration experience OR Bachelor’s degree and 4 years of life science, computer science, business administration experience OR Associate’s degree and 8 years of life science, computer science, business administration experience OR High school diploma / GED and 10 years of life science, computer science, business administration experience

Preferred Qualifications

5 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.) . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen