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Amgen

Makes biotech medicines for serious illnesses

Central Monitor Senior Associate

Clinical Research OperationsPosted on Nov 10
Full-timeHyderabad, Telangana, IndiaNo salary listedIn-person

About the Job

Requirements

  • Graduate or postgraduate qualification with at least 4 years of experience in central monitoring.
  • 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 analyzing broad clinical trial data sets for trends.
  • Experience with central monitoring tools and methodologies, structured review, and producing inspection-ready documentation.
  • Demonstrated ability to mentor and coach junior team members.

Responsibilities

  • Execute proactive, data-driven risk surveillance for assigned studies and 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 actionable insights and escalate high-impact risks appropriately and promptly.
  • Support implementation and monitoring of risk-based quality management strategies, such as site risk assessments, key risk indicators, and quality tolerance limits, in partnership with Central Monitors and Data Delivery Leads; contribute to continuous refinement based on observed signals and study trends.
  • Conduct study-specific and study-level analytics and site/study metric-trend reviews; synthesize insights across data sources; align with study teams on targeted actions and track them through resolution and closure.
  • Maintain high-quality, inspection-ready documentation of signal-detection outputs, rationale, decisions, and recommended actions in line with regulatory and internal governance expectations.
  • Engage effectively with study teams, clinical research associates, and functional partners to ensure timely issue resolution and reinforce continuous quality improvement.
  • Mentor and support junior central monitors through knowledge sharing, targeted coaching, and review of deliverables and outputs.

Desired Qualifications

  • Four to eight years of work experience in life sciences or a medically related field, including centralized monitoring or centralized review experience with increasing independence.

About the Company

Amgen

Makes biotech medicines for serious illnesses

Amgen develops and makes biologic medicines, which are drugs built from proteins and antibodies grown in living cells, for serious conditions such as heart disease, cancer, and bone loss. Its anemia drug Epogen, approved in 1989, became one of the biotechnology industry's first blockbuster medicines. Amgen grows these drugs in large tanks called bioreactors, and its products include the cholesterol drug Repatha, the bone-building drug Evenity, and the severe asthma drug Tezspire. It earns money by selling these medicines, mostly through large drug wholesalers that supply hospitals and pharmacies. Amgen was founded in 1980 and is based in Thousand Oaks, California.

Company size
10,001+
Company stage
IPO
Headquarters
Thousand Oaks, CA
Founded
1980

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