Central Monitor | Novartis
Company: Novartis Careers
Job ID: REQ-10070501
Position: Central Monitor (Clinical Trials / RBQM)
Location: Hyderabad
Division: Development
Business Unit: Clinical Development
Employment Type: Full-Time | Regular
Posted On: April 16, 2026
Role Overview
The Central Monitor is responsible for centralized oversight of clinical trials using data analytics and risk-based monitoring (RBM/RBQM) approaches.
The role focuses on:
Monitoring clinical trial data centrally (not just site-based monitoring)
Detecting risks and trends early using data signals
Improving patient safety and data quality
Supporting proactive risk management across trials
This position is a core part of Risk-Based Quality Management (RBQM) in clinical research.
Key Responsibilities
1. Centralized Monitoring Execution
Execute centralized monitoring strategies for clinical trials
Analyze clinical trial datasets to identify trends, anomalies, and signals
Review outputs from central monitoring systems and tools
Support definition of data domains required for monitoring
Ensure compliance with RBM plans, SOPs, and GCP standards
2. Risk Detection & Surveillance
Identify risks using Key Risk Indicators (KRIs)
Detect atypical data patterns across sites and studies
Contribute to trial-level risk assessment and mitigation
Support root cause analysis of issues
Recommend corrective and preventive actions
3. Collaboration with Data & Analytics Teams
Work closely with data analysts for system outputs
Validate and interpret risk signals
Ensure proper configuration of central monitoring tools
Align monitoring outputs with study risk strategies
4. Clinical Trial Team Collaboration
Partner with:
Clinical Trial Teams (CTTs)
Risk Surveillance Leads (RSLs)
Data Managers
Clinical Scientists
Responsibilities include:
Participating in study team meetings
Providing data-driven recommendations
Acting as single point of contact for CM activities
Supporting development of Trial Monitoring Plans
5. Risk-Based Quality Management (RBQM)
Support implementation of RBQM frameworks
Contribute to Key Risk Indicator (KRI) design and thresholds
Support Quality Tolerance Limits (QTL) monitoring
Ensure early identification of study risks
Enable data-driven monitoring interventions
6. Reporting & Documentation
Document monitoring findings in central systems
Communicate risks to study teams and stakeholders
Escalate critical issues appropriately
Maintain audit-ready documentation
Ensure timely reporting of signals and trends
7. Continuous Improvement & Compliance
Improve centralized monitoring methodologies
Support training and knowledge sharing
Ensure adherence to:
Good Clinical Practice (GCP)
ICH guidelines
Internal Novartis standards
Contribute to process optimization in RBQM
Required Qualifications
Education
Degree in Life Sciences, Business, Operations, or related field
Strong English proficiency (written & spoken)
Experience
Required:
5+ years in pharmaceutical or CRO industry
Experience in clinical research or clinical trial operations
3+ years in monitoring activities (site or central monitoring preferred)
Preferred:
Hands-on Central Monitoring experience
KRI/QTL experience
Risk-Based Monitoring (RBM/RBQM) exposure
Clinical data analytics or data management background
Technical & Domain Skills
Strong knowledge of:
Clinical trial processes
Risk-Based Quality Management (RBQM)
Risk-Based Monitoring (RBM)
Key Risk Indicators (KRIs)
Quality Tolerance Limits (QTLs)
Clinical data interpretation
ICH-GCP guidelines
Drug development lifecycle
Analytical Skills
Must be able to:
Analyze complex clinical datasets
Identify patterns, anomalies, and risk signals
Interpret operational and clinical risk indicators
Provide actionable insights for trial optimization
Soft Skills
Strong critical thinking
Attention to detail
Strong communication skills
Stakeholder management
Ability to work in cross-functional teams
Decision-making under uncertainty
Proactive risk identification mindset
Role Importance
This role is essential for:
Ensuring patient safety in clinical trials
Improving trial data quality
Enabling early risk detection
Supporting efficient and compliant clinical development
Strengthening RBQM capabilities globally
Why Novartis?
This role gives you the opportunity to:
Work on global clinical trials
Influence patient safety outcomes
Use advanced data-driven monitoring systems
Contribute to cutting-edge RBQM transformation
Collaborate with global clinical development teams
Helpful Links
Careers
People & Culture
Benefits & Rewards
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