Amgen is hiring for the position of Central Monitor Senior Associate in Hyderabad, India. This full-time, on-site opportunity is part of the Clinical Development career category and is suitable for graduates and postgraduates with 4 or more years of experience in central monitoring.

The role focuses on clinical trial data analysis, risk-based quality management (RBQM), signal detection, and centralized monitoring to support patient safety, data quality, and protocol adherence.

Amgen Central Monitor Senior Associate Job Details

Position: Central Monitor Senior Associate

The selected candidate will independently conduct proactive, data-driven central monitoring for assigned clinical studies and sites. The role involves identifying trends, anomalies, and emerging risks in clinical trial data and translating findings into actionable recommendations for study teams.

The position also includes supporting risk-based monitoring strategies, maintaining inspection-ready documentation, collaborating with clinical research teams, and mentoring junior central monitors.

Responsibilities

Key responsibilities of the Central Monitor Senior Associate at Amgen include:

• Execute data-driven risk surveillance for assigned clinical studies and sites using central monitoring analytics.
• Identify, assess, and prioritize signals, trends, anomalies, and emerging clinical trial risks.
• Translate statistical and operational findings into actionable insights and escalate high-impact risks when necessary.
• Support risk-based quality management (RBQM) strategies, including Study Risk Assessments (SRAs), Key Risk Indicators (KRIs), and Quality Tolerance Limits (QTLs).
• Review study-level analytics, site metrics, and trends across multiple data sources.
• Coordinate with study teams to implement targeted actions and track issues through resolution and closure.
• Maintain accurate, inspection-ready documentation of monitoring signals, decisions, rationale, and recommended actions.
• Collaborate with Clinical Research Associates (CRAs), study teams, and functional partners to resolve issues promptly.
• Mentor junior central monitors through knowledge sharing, coaching, and review of their work.

Eligibility and Qualifications

Candidates applying for the Amgen Central Monitor Senior Associate job should meet the following requirements.

Basic Qualifications

• Graduate or postgraduate qualification.
• At least 4 years of experience in central monitoring.

Preferred Qualifications

• 4–8 years of work experience in life sciences or a medically related field.
• Experience in centralized monitoring or centralized review, with increasing levels of independence.
• Experience working with clinical trial teams across multiple geographies on global clinical trials.
• Knowledge of risk-based monitoring (RBM), risk-based quality management (RBQM), and/or clinical site management.
• Experience analyzing broad clinical trial datasets to identify trends.
• Familiarity with central monitoring tools, methodologies, structured reviews, and inspection-ready documentation.
• Demonstrated ability to mentor and coach junior team members.

Required Skills

Candidates should have relevant experience or knowledge in the following areas:

• Centralized clinical trial monitoring
• Clinical trial data analysis and trend identification
• Signal detection, risk triage, and prioritization
• Risk-Based Quality Management (RBQM)
• Risk indicators, including KRIs and QTLs
• Study-level and site-level metrics review
• Clinical trial quality and protocol adherence
• Regulatory documentation and inspection readiness
• Cross-functional stakeholder collaboration
• Mentoring and coaching junior team members