Lead Central Monitor
Job ID: REQ-10047951
April 9, 2025
Location: India
Summary
The Lead Central Monitor (Lead CM) supports the Central Monitoring Head in driving excellence in clinical trial monitoring by establishing and delivering state-of-the-art Central Monitoring (CM) capabilities at Novartis in Global Clinical Operations (GCO). This role involves managing a team of Central Monitors, developing monitoring strategies, and ensuring the proper configuration of CM platforms for risk identification and surveillance.
Key Responsibilities:
CM Establishment
Support the creation and implementation of a CM function, including processes, tools, and governance frameworks to support Risk-Based Quality Management (RBQM).
Contribute to the CM resourcing strategy (hiring, onboarding, development) and monitor CM objectives.
Team Leadership and Oversight
Lead and mentor a team of Central Monitors, ensuring alignment with CM processes and maintaining high performance.
Serve as the primary escalation point for CMs, providing guidance on complex risk signals and critical study-related risks.
Strategic Input and Coordination
Partner with the CM Head to implement CM strategies, focusing on continuous improvement in RBQM processes.
Harmonize CM practices across studies to ensure consistent risk detection and escalation protocols.
Risk Management and Analytics Leadership
Oversee the analysis and interpretation of CM dashboards and tools to identify and contextualize risk signals.
Collaborate with cross-functional teams to ensure effective risk mitigation plans are in place.
Protocol and Study Design Support
Provide input during protocol development and study setup to align with RBQM objectives.
Advise on KRI design and optimization to enhance CM effectiveness.
Data Integrity and Quality
Ensure trial data surveillance for quality and integrity in clinical trials.
Serve as a liaison between the CM team and Clinical Trial Teams (CTTs), ensuring clear communication of risk management priorities.
Performance Tracking and Continuous Improvement
Monitor and report on the effectiveness of CM activities, identifying opportunities for process improvements.
Share insights and lessons learned to build organizational capability in RBQM.
Documentation and Compliance
Ensure comprehensive documentation of CM activities, meeting regulatory and internal quality requirements.
Oversee audit readiness and support inspections for regulatory compliance.
Technology and Innovation Leadership
Act as a stakeholder in evaluating and improving CM tools and technologies.
Drive innovation in data analytics and visualization techniques to enhance risk identification and monitoring.
Essential Requirements:
Education: Degree in a relevant field (e.g., Life Sciences, Clinical Research).
Experience: Proven experience in clinical trial monitoring, with expertise in risk-based monitoring strategies.
Skills:
Knowledge of CM, RBQM, risk management, and clinical trial processes.
Expertise in data analytics, technology integration, and visualization tools.
Strong leadership and team management abilities.
Languages: Proficiency in English.
Desirable Requirements:
Work Experience: Experience leading teams in clinical trial monitoring.
Skills: Strong strategic thinking and problem-solving capabilities.
Why Novartis:
Novartis is dedicated to reimagining medicine to improve and extend people's lives. Join a community of passionate individuals driving breakthroughs to change patients' lives.
For more information on benefits and career opportunities, visit Novartis Careers.
Division: Development
Business Unit: Innovative Medicines
Location: Hyderabad (Office)
Company: Novartis Healthcare Private Limited
Functional Area: Research & Development
Employment Type: Full time
Shift Work: No
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