SummaryThe Central Monitor (CM) plays a key role for Data Surveillance by overseeing and supporting clinical trials through centralized monitoring activities. This role ensures data quality, identifies potential risks, and enhances trial oversight by leveraging data analytics and risk-based monitoring strategies. The CM collaborates with cross-functional teams to ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. The CM will play a vital role in the study Risk-Based Quality Management process. The role will have a key responsibility in connecting with the Data Analysts team, ensuring that the Central Monitoring technology is appropriately configured. During trial execution, the CM is responsible for ongoing aggregate Data Surveillance utilizing Central Monitoring technology to monitor data quality, patient safety, and relevant risks, interpreting and contextualizing risk signals for communication to the Clinical Trial Teams (CTTs) as well as to field monitoring teams and Risk Surveillance Team.
SummaryThe Central Monitor (CM) plays a key role for Data Surveillance by overseeing and supporting clinical trials through centralized monitoring activities. This role ensures data quality, identifies potential risks, and enhances trial oversight by leveraging data analytics and risk-based monitoring strategies. The CM will play a vital role in the study Risk-Based Quality Management process. The role will have a key responsibility in connecting with the Data Analysts team, ensuring that the Central Monitoring technology is appropriately configured. During trial execution, the CM is responsible for ongoing aggregate Data Surveillance utilizing Central Monitoring technology to monitor data quality, patient safety, and relevant risks, interpreting and contextualizing risk signals for communication to the Clinical Trial Teams (CTTs) as well as to field monitoring teams and Risk Surveillance Team.





About The Role
Key ResponsibilitiesCentral Monitoring ExecutionExecute centralized monitoring strategies to support clinical trial oversight.
Perform ongoing review and analysis of clinical trial data to identify trends, risks, and signals.
Collaborate with Data Analysts to review technology outputs and investigate identified risks.
Provide input into data requirements and monitoring strategies.
Risk Identification and ManagementConduct data surveillance through Central Monitoring platforms.
Identify potential site and study-level risks in alignment with the Integrated Quality Risk Management Plan (IQRMP). Support the implementation and refinement of risk-based monitoring plans.
Provide risk-based recommendations to improve trial quality and efficiency.
Contribute to root cause analyses and corrective action discussions.
Data Review and ReportingGenerate and communicate Central Monitoring findings and insights.
Support Data Quality Teams in assessing the significance and root causes of findings.
Document monitoring activities, findings, and risk escalations.
Collaboration and Stakeholder EngagementPartner with Risk Surveillance Leads (RSLs), Study Leaders, Data Managers, Clinical Scientists, and other stakeholders.
Contribute to knowledge sharing, training, and best practice development across the Central Monitoring organization.
Minimum 3 years of monitoring experience (central or site monitoring). Strong understanding of RBQM, centralized monitoring, KRIs, QTLs, and clinical trial risk management.
Working knowledge of ICH-GCP and international drug development standards.
Experience interpreting complex clinical and operational data.
Excellent communication, stakeholder management, and cross-functional collaboration skills.
Experience working within a general matrix organization.
Proficiency with clinical data systems, analytics platforms, and digital tools.
Strong project management and organizational skills.

📌 Data Lead and Manager (España)
🏢 Novartis
📍 España