Central Monitor

Career Category Clinical Development Job Description 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. Central Monitor What you will do Let’s do this. Let’s change the world. In this vital role you will lead proactive, data-driven central monitoring across clinical programs, applying advanced analytics and structured review to detect early signals that may impact patient safety, data quality, and protocol adherence, and translating these into actionable insights that improve study execution. Lead proactive, data-driven risk surveillance across studies using central monitoring analytics to detect trends, anomalies, and emerging risks Translate complex statistical and operational findings into clear, actionable insights, recommending targeted interventions to study teams, CRAs, and functional leads Partner closely with Data Delivery Leads to implement, monitor, and continuously refine RBQM strategies (e.g., QTLs, KRIs, SRAs) across the study lifecycle Act as a subject matter expert in central monitoring tools and methodologies, driving consistent use and elevating team capability in signal detection and interpretation Document signal detection outputs, rationale, and recommended actions in an inspection-ready manner aligned with regulatory and internal governance expectations Facilitate feedback loops across sites, CRAs, and study teams to ensure issues are resolved and drive continuous process and quality improvement across the portfolio What we expect of you We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an individual with the following qualifications. Basic Qualifications: Doctorate/ Master’s degree with 8-15 years of clinical execution experience Preferred Qualifications: Minimum 8 years of work experience in life sciences or medically related field, including 3+ years of managing data on biopharmaceutical clinical research experience Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management Experience in analyzing broad clinical trial data sets for trends What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. .