Amgen—Central Monitor Senior Associate

Job description

Description: 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 Senior Associate What you will do Let’s do this. Let’s change the world. In this vital role you will independently execute proactive, data-driven central monitoring across assigned studies, applying 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. - Execute proactive, data-driven risk surveillance for assigned studies/sites using central monitoring analytics to detect trends, anomalies, and emerging risks - Perform independent signal detection, triage and prioritization; translate statistical and operational findings into clear, actionable insights - with appropriate and timely escalation of high-impact risks - Support implementation and monitoring of RBQM strategies (e.g., SRAs,KRIs,QTLs) in partnership with Central Monitors/Data Delivery Leads; contribute to continuous refinement based on observed signals and study trends - Conduct study-specific/level analytics and site/study metrics -trend reviews; - synthesizing insights across data sources; align with study teams on targeted actions and track through resolution and closure - Ensure high-quality, inspection-ready documentation of signal detection outputs, rationale, decisions, and recommended actions in line with regulatory and internal governance expectations - Maintain effective stakeholder engagement with study teams, CRAs, and functional partners to ensure timely issue resolution and reinforce a feedback loop for continuous quality improvement - Mentor and support junior central monitors; contributing to capability building -through knowledge sharing, targeted coaching, and review of deliverables/outputs. 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: - Graduate/Postgraduate with 4+ years of experience in central monitoring Preferred Qualifications: - 4-8 years’ work experience in life sciences or medically related field, including experience performing centralized monitoring / centralized review with increasing independence - 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 - Experience in central monitoring tools and methodologies; ability to consistently apply structured review and produce inspection-ready documentation - Demonstrated mentoring/coaching ability for junior team members 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. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: - Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. - Award-winning time-off plans and bi-annual company-wide shutdowns - Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com 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. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .