Central Monitor

Amgen Inc. (IR); Hyderabad; On-site; INR 3,000,000 - 4,200,000; Full time

Job summary

Amgen Inc. is seeking a Senior Central Monitor to lead proactive, data-driven central monitoring across clinical programs, applying analytics to detect signals that may impact patient safety and data quality.

You will translate complex results into actionable insights for study teams and functional leads. You will partner with Data Delivery Leads to refine RBQM strategies across the study lifecycle and act as a subject matter expert in central monitoring tools and methodologies, driving

Qualifications

• Doctorate or Master’s degree with 8–15 years of clinical execution experience.
• 8+ years of work in life sciences or medically related field, including 3+ years of managing data on biopharmaceutical clinical research.
• Experience with risk-based monitoring models / risk-based quality management and clinical site management.

Responsibilities

• Lead proactive, data-driven central monitoring across clinical programs to detect signals impacting safety and data quality.
• Translate findings into actionable insights for study teams and leads.
• Partner with Data Delivery Leads to implement RBQM strategies throughout study lifecycle.
• Act as SME in central monitoring tools and methodologies and drive best practices.

Skills

Data analysis

Clinical trial experience

Risk-based monitoring

Education

Doctorate/Master's degree

Tools

RBQM tools

Job 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

What you will do

Let’s do this. Let’s change the world.

• 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.

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.

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.

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