Central Monitor – Clinical Data Surveillance
Job ID: REQ-10070501
Location: Hyderabad, India
Employment Type: Full-Time | Regular
Functional Area: Research & Development
Business Unit: Development
Company: Novartis Healthcare Private Limited
Posted On: February 3, 2026
Role Overview
The Central Monitor (CM) plays a critical role in centralized data surveillance and risk-based quality management for global clinical trials. This position supports proactive trial oversight by leveraging centralized monitoring technologies, advanced data analytics, and risk-based monitoring (RBM) strategies to ensure data integrity, patient safety, and regulatory compliance.
The Central Monitor is actively involved throughout the clinical trial lifecycle, working closely with the Risk Surveillance Lead (RSL), Clinical Trial Teams (CTTs), Data Analysts, and other cross-functional stakeholders. The role is instrumental in identifying, assessing, and mitigating study-related risks through Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and continuous data surveillance.
Key Responsibilities
Centralized Monitoring and Data Surveillance
Execute centralized monitoring activities in alignment with approved Risk-Based Monitoring and Risk-Based Quality Management (RBQM) strategies.
Perform ongoing aggregate data surveillance using centralized monitoring platforms to detect trends, anomalies, and potential risk signals.
Collaborate with Data Analytics teams to review system outputs, interpret atypical data patterns, and perform preliminary investigations prior to escalation.
Provide input on data domains required for effective centralized monitoring as defined in study monitoring strategies.
Risk Identification and Mitigation
Identify site-level and study-level risks in accordance with the Integrated Quality Risk Management Plan (IQRMP).
Support early risk identification, risk assessment, and definition of oversight measures, including KRIs and monitoring thresholds.
Conduct root cause analysis for identified findings and recommend corrective and preventive actions.
Generate, document, and summarize centralized monitoring findings and communicate results to study teams, RSLs, and relevant governance bodies.
Cross-Functional Collaboration
Act as the primary point of contact for centralized monitoring activities for assigned studies.
Participate as a member of the Clinical Trial Team, providing data-driven insights and recommendations during study team meetings.
Serve as a key interface between Central Monitoring, Clinical Operations, Data Management, and Risk Surveillance teams.
Contribute to the development and maintenance of Trial Monitoring Plans, ensuring coverage of standard and study-specific risks.
Compliance and Continuous Improvement
Ensure adherence to ICH-GCP, regulatory requirements, internal SOPs, and Novartis quality standards.
Support continuous improvement initiatives for centralized monitoring methodologies and tools.
Contribute to training, knowledge-sharing, and best practice development within the Central Monitoring function.
Required Qualifications
Education
University degree in Life Sciences, Business, Operations, or a related discipline.
Experience
Minimum 5 years of pharmaceutical industry experience, with demonstrated involvement in clinical research within a pharmaceutical company or CRO.
At least 3 years of hands-on experience in clinical trial monitoring, including centralized monitoring and/or site monitoring.
Strong preference for candidates with direct experience in centralized monitoring, KRIs, QTLs, and RBQM frameworks.
Prior exposure to clinical data analytics, data management, or related functions is highly desirable.
Skills and Competencies
Strong understanding of clinical trial development, risk management processes, and end-to-end trial execution.
In-depth knowledge of international clinical research standards, including ICH-GCP and global regulatory expectations.
Advanced analytical and critical thinking skills with the ability to interpret complex clinical and operational datasets.
Proven ability to identify trends, outliers, and risk signals and translate findings into actionable insights.
Excellent written and verbal communication skills in English.
Strong collaboration skills with the ability to influence cross-functional stakeholders.
Why Join Novartis
Novartis is driven by a mission to reimagine medicine and improve patients’ lives through innovative science and collaborative excellence. The organization fosters an inclusive, high-performance culture where diverse perspectives are valued and professional growth is actively supported.
Employees benefit from competitive rewards, learning opportunities, and a workplace committed to integrity, inclusion, and long-term impact on global health.
Diversity, Inclusion, and Accessibility
Novartis is an Equal Opportunity Employer committed to building diverse teams that reflect the patients and communities it serves. Reasonable accommodations are available for individuals with disabilities throughout the recruitment and employment process. Requests for accommodation may be submitted with reference to the job requisition number.
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