Central Monitoring & Data Surveillance Lead

Novartis; Barcelona; On-site; EUR 65,000 - 95,000; Full time

Job summary

Novartis is seeking a Central Monitor (CM) to oversee data surveillance and centralized monitoring across clinical trials, ensuring data quality, safety signals, and regulatory compliance. The CM will collaborate with Data Analysts, Study Leaders, and other stakeholders to interpret risk indicators and refine monitoring plans within the RBQM framework.

You will contribute to the risk-based quality management process, support implementation of monitoring strategies, and ensure use of RBM tools

Qualifications

• Minimum 5 years in clinical research within pharma or CRO
• Minimum 3 years of central or site monitoring experience
• Strong understanding of RBQM, central monitoring and KRIs
• Working knowledge of ICH-GCP and international standards
• Excellent communication and cross-functional collaboration skills

Responsibilities

• Execute centralized monitoring strategies to support trial oversight
• Review and analyze trial data to identify trends, risks, signals
• Collaborate with Data Analysts to review outputs and investigate risks
• Provide input into data requirements and monitoring strategies
• Ensure adherence to RBM plans and SOPs
• Identify potential site/study risks and support risk management
• Generate and communicate monitoring findings and insights
• Document activities, findings and risk escalations
• Partner with RSLs, Study Leaders, Data Managers and other stakeholders
• Contribute to development and maintenance of Trial Monitoring Plans
• Support advancement of monitoring methodologies and tools
• Ensure compliance with GCP and regulatory requirements

Skills

RBQM

Centralized monitoring

Data analytics

Risk management

Communication

Stakeholder management

Clinical data systems

Project management

Education

University degree in Life Sciences, Business, Operations, or related discipline

Tools

Clinical Data Systems

Analytics Platforms

Digital Tools

Job description

Novartis is seeking a Central Monitor (CM) to oversee data surveillance and centralized monitoring across clinical trials, ensuring data quality, safety signals, and regulatory compliance. The CM will collaborate with Data Analysts, Study Leaders, and other stakeholders to interpret risk indicators and refine monitoring plans within the RBQM framework.

You will contribute to the risk-based quality management process, support implementation of monitoring strategies, and ensure use of RBM tools