Central Monitor Manager

Amgen Technology; Hyderabad; Sur place; INR 1 500 000 - 2 100 000; Plein temps

Résumé du poste

Amgen Technology in Hyderabad, India, is seeking a Central Monitor to lead data-driven central monitoring across clinical programs. You will apply advanced analytics to detect early signals impacting patient safety, data quality, and protocol adherence.

You will partner with study teams and RBQM leads to implement risk-based monitoring and translate findings into actionable interventions, ensuring inspection-ready documentation and continuous process improvements.

Qualifications

• Doctorate or master’s degree with 8–15 years clinical execution experience.
• Experience with RBM tools and signal detection.
• Experience across global clinical trials in multiple geographies.
• Strong data analysis of clinical trial datasets.

Responsabilités

• Lead proactive, data-driven risk surveillance across studies using central monitoring analytics.
• Translate findings into actionable interventions for study teams and leads.
• Collaborate with Data Delivery Leads to implement RBQM strategies.
• Act as SME in central monitoring tools and methodologies.
• Document outputs in inspection-ready format with rationale.
• Facilitate feedback loops across sites and teams to drive quality improvements.

Connaissances

Data-driven monitoring

Risk surveillance

Signal detection

Cross-functional collaboration

Formation

Doctorate or Masters degree

Outils

CluePoints

Description du poste

Job Summary

Central Monitor

What you will do

Lets do this. Lets 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.

Responsibilities

• 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

Requirements

Basic Qualifications

• Doctorate/Masters degree with 8-15 years of clinical execution experience

Preferred Qualifications

• Minimum 8 years of work experience in life sciences or medically related field and managing data on biopharmaceutical clinical research experience.
• Experience with Risk-Based Monitoring (RBM) tools such as CluePoints is highly preferred.
• 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