Central Monitoring Lead Risk-Based Quality Management (RBQM)

Why This Role Matters

Novartis is a global pharmaceutical leader committed to advancing innovative therapies across multiple therapeutic areas. In modern clinical trials, centralized monitoring has become a critical component of Risk-Based Quality Management (RBQM), ensuring patient safety, data integrity, and regulatory compliance.
The Central Monitor (CM) plays a strategic role in Data Surveillance by leveraging analytics-driven oversight to detect risks early, interpret data trends, and support proactive mitigation strategies. This position is essential for ensuring clinical trials meet ICH-GCP standards while maintaining operational efficiency and high-quality outcomes.

Job Description

The Central Monitor (CM) oversees and supports clinical trials through centralized monitoring activities. This role ensures data quality, identifies potential risks, and enhances trial oversight using data analytics and risk-based monitoring methodologies.
The CM collaborates closely with Risk Surveillance Leads (RSLs), Clinical Trial Teams (CTTs), Data Analysts, and other cross-functional stakeholders to detect study-related risks early and implement appropriate oversight measures, including Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs).The role is involved from early study stages through execution and contributes significantly to the RBQM lifecycle.

Key Features of the Role

• Strategic role in Risk-Based Quality Management (RBQM)
• Involvement from study start-up through trial execution
• Data-driven clinical oversight function
• Cross-functional collaboration with global study teams
• Exposure to advanced Central Monitoring technologies
• Opportunity to influence trial efficiency and patient safety

Responsibilities Required

Central Monitoring Execution

• Implement and execute centralized monitoring strategies
• Conduct ongoing aggregate data surveillance using CM technology
• Review CM outputs and perform initial investigation of atypical data patterns
• Provide input into data domains required for central monitoring
• Ensure adherence to monitoring strategy, SOPs, and best practices
• Develop Trial Monitoring Plans addressing standard and study-specific risks

Risk Identification and Management

• Perform data surveillance via CM platform aligned with IQRMP
• Identify site-level and trial-level risks using KRIs and QTLs
• Collaborate with Lead CM and study teams to refine monitoring strategies
• Conduct root cause analysis and suggest corrective actions
• Generate and summarize findings within CM platform
• Escalate critical risks and support follow-up actions
• Support DQT in assessing criticality and root causes

Cross-Functional Collaboration

• Act as single point of contact for CM activities for allocated studies
• Participate as CTT member in study team meetings
• Communicate risk signals to Clinical Trial Teams and field monitoring teams
• Serve as interface between Central Monitoring and Clinical Study Teams
• Provide data-driven recommendations to enhance trial oversight
• Ensure timely documentation of monitoring activities

Continuous Improvement and Compliance

• Support improvement of centralized monitoring methodologies
• Ensure compliance with regulatory requirements, SOPs, and GCP
• Contribute to training and knowledge-sharing initiatives
• Advise on design and optimization of KRIs and thresholds

Qualifications

• University degree in Life Sciences
• Degree in Business or Operations
• Equivalent relevant academic qualification

Educational Requirements

• Recognized university degree
• Strong understanding of clinical research methodologies
• Knowledge of international regulatory standards preferred

Experience and Skills

Experience

• ≥ 5 years of pharmaceutical industry experience
• Prior clinical research experience within Pharmaceutical Industry or CRO
• ≥ 3 years of comprehensive monitoring experience (central or site)
• Experience in clinical data analytics or data management preferred
• Hands-on experience with KRIs, centralized monitoring, and QTLs strongly preferred
• Experience supporting RFP-level monitoring strategy (advantageous)

Technical Knowledge

• Strong understanding of Risk-Based Quality Management (RBQM)
• Knowledge of adaptive monitoring principles
• Thorough understanding of international standards (ICH-GCP)
• Knowledge of global drug development processes
• Familiarity with health authority regulations

Core Skills

• Strong analytical and critical thinking ability
• Ability to interpret complex clinical and operational data
• Risk identification and signal detection expertise
• Excellent communication skills (written and spoken English)
• Collaboration across global teams
• Documentation accuracy and regulatory compliance awareness

Competencies

• Strategic thinker with strong risk evaluation capability
• Detail-oriented and data-driven professional
• Strong cross-functional collaboration skills
• Ability to manage complex data environments
• Adaptable to dynamic, multi-study environments
• Strong organizational and communication skills

Salary Insights

• Competitive compensation package (based on experience and location)
• Exposure to global clinical trial programs
• Opportunity to work within advanced RBQM frameworks
• Career progression into Lead CM, Risk Surveillance Lead, or Clinical Operations Leadership roles

Company Overview

Novartis is a global healthcare company focused on reimagining medicine to improve and extend people’s lives. The organization operates across multiple therapeutic areas and adheres to rigorous international standards in clinical development.
Novartis is committed to Diversity and Inclusion and provides reasonable accommodation support for individuals with disabilities throughout the recruitment and employment lifecycle.

FAQs

1. Is central monitoring experience mandatory?
   Strongly preferred, especially hands-on KRI and QTL experience.

2. Is site monitoring experience acceptable?
   Yes, comprehensive monitoring experience (central or site) is required.

3. Is this a global role?
   Yes, it involves collaboration with global cross-functional teams.

4. What regulatory knowledge is required?
   Strong understanding of ICH-GCP and international drug development standards.

5. Career growth opportunities?
   Progression into Lead CM, Risk Surveillance Lead, or Clinical Operations leadership roles.

Application Tips

• Revise RBQM and centralized monitoring principles
• Prepare examples of risk signal detection handled
• Highlight experience with KRIs and QTL frameworks
• Demonstrate data analytics and trend analysis capabilities
• Showcase cross-functional collaboration experience
• Emphasize regulatory knowledge and compliance awareness