Central Monitor (Data Surveillance Lead)

IN10 (FCRS = IN010) Novartis Healthcare Private Limited; Hyderabad; On-site; INR 2,000,000 - 4,000,000; Full time

Job summary

Novartis Healthcare Private Limited in Hyderabad is seeking a Central Monitor to oversee data surveillance in clinical trials, applying RBM strategies, KRIs, and QTLs to ensure data quality and patient safety across studies. You will partner with cross-functional teams, interpret risk signals, contribute to monitoring plans, and help maintain compliance with GCP and ICH standards.

This role requires a life sciences or related degree and at least 5 years in clinical research or monitoring, with

Qualifications

• University degree in Life Sciences, Business, Operations, or related discipline.
• Minimum 5 years of experience in clinical research within pharmaceutical industry or CRO.
• Minimum 3 years of monitoring experience (central or site).
• Strong understanding of RBQM, centralized monitoring, KRIs, QTLs, and clinical trial risk management.
• Working knowledge of ICH-GCP and international drug development standards.

Responsibilities

• Execute centralized monitoring strategies to support clinical trial oversight.
• Review and analyze clinical trial data to identify trends, risks, and signals.
• Collaborate with Data Analysts to review outputs and investigate risks.
• Ensure adherence to RBM plans, SOPs, and industry best practices.
• Identify potential site and study-level risks in alignment with IQRMP.
• Support 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.
• Generate and communicate Central Monitoring findings and insights.
• Document monitoring activities, findings, and risk escalations.
• Ensure timely follow-up and resolution of identified issues.
• Partner with Risk Surveillance Leads, Study Leaders, Data Managers, and other stakeholders.
• Participate as an active Clinical Trial Team member.
• Serve as primary point of contact for Central Monitoring activities within assigned studies.
• Contribute to the development and maintenance of Trial Monitoring Plans.
• Support advancement of centralized monitoring methodologies and tools.
• Ensure compliance with GCP, regulatory requirements, and Novartis standards.
• Contribute to knowledge sharing, training, and best practice development across the Central Monitoring organization.

Skills

RBQM

Centralized monitoring

KRIs

QTLs

Clinical trial risk management

Analytical skills

Communication

Stakeholder management

Cross-functional collaboration

Project management

Organizational skills

Education

University degree in Life Sciences/Business/Operations

Job description

Job Description Summary

The 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. This role is key to detect any study related risk/issue(s) within the scope of study RBM strategy. The CM will be involved early during clinical trial lifetime, working alongside the Risk Surveillance Lead (RSL) and others to support risk identification, risk assessment, definition of risk oversight measures (ex: Key Risk Indicators - KRIs). 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.

Job Description Key Responsibilities

• Central Monitoring Execution

  • Execute 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.
  • Ensure adherence to RBM plans, SOPs, and industry best practices.

• Risk Identification and Management

  • Conduct 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 Reporting

  • Generate 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.
  • Ensure timely follow-up and resolution of identified issues.

• Collaboration and Stakeholder Engagement

  • Partner with Risk Surveillance Leads (RSLs), Study Leaders, Data Managers, Clinical Scientists, and other stakeholders.
  • Participate as an active Clinical Trial Team (CTT) member.
  • Serve as the primary point of contact for Central Monitoring activities within assigned studies.
  • Contribute to the development and maintenance of Trial Monitoring Plans.

• Continuous Improvement and Compliance

  • Support advancement of centralized monitoring methodologies and tools.
  • Ensure compliance with GCP, regulatory requirements, and Novartis standards.
  • Contribute to knowledge sharing, training, and best practice development across the Central Monitoring organization.

Essential Requirements

• University degree in Life Sciences, Business, Operations, or a related discipline.
• Minimum 5 years of experience in clinical research within the pharmaceutical industry or CRO environment.
• 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.
• Strong analytical, critical thinking, and problem-solving skills.Experience interpreting complex clinical and operational data.
• Excellent communication, stakeholder management, and cross-functional collaboration skills.
• Experience working within a global matrix organization.
• Proficiency with clinical data systems, analytics platforms, and digital tools.
• Strong project management and organizational skills.

Skills Desired

• Clinical Research
• Clinical Study Reports
• Clinical Trials
• Collaboration
• Data Analysis
• Financial Analysis
• Health Sciences

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