Central Monitor – Clinical Data Surveillance / Risk-Based Monitoring
Job ID: REQ-10070501
Location: Hyderabad, India (Office-Based)
Employment Type: Full Time | Regular
Division: Development
Functional Area: Research & Development
Company: Novartis Healthcare Private Limited
Job Overview
ThePharmaDaily.com is featuring an advanced opportunity for a Central Monitor within Clinical Development. This role plays a critical part in centralized monitoring, data surveillance, and Risk-Based Quality Management (RBQM) across global clinical trials.
The Central Monitor (CM) is responsible for leveraging data analytics and centralized monitoring technology to ensure patient safety, data integrity, and proactive risk mitigation throughout the clinical trial lifecycle. The role collaborates closely with Clinical Trial Teams (CTTs), Risk Surveillance Leads (RSLs), Data Analysts, and cross-functional stakeholders to detect, interpret, and escalate study-related risks in alignment with regulatory and GCP standards.
Experience Level
Senior / Experienced Professional
Experience Required:
Minimum 5+ years of recent pharmaceutical or CRO experience in clinical research.
At least 3+ years of hands-on experience in central monitoring and/or site monitoring.
Experience in clinical data analytics, risk-based monitoring, and RBQM processes strongly preferred.
Key Responsibilities
Central Monitoring Execution
Implement and execute centralized monitoring strategies aligned with RBQM principles.
Conduct ongoing aggregate data surveillance to detect risk signals, trends, and outliers.
Review centralized monitoring outputs and perform initial investigation of atypical data patterns.
Ensure proper configuration and optimization of central monitoring technology platforms.
Contribute to the development and execution of Trial Monitoring Plans.
Risk Identification and Management
Identify site-level and study-level risks in alignment with Integrated Quality Risk Management Plans (IQRMP).
Collaborate with Lead CM and study teams to refine risk-based monitoring strategies.
Support root cause analysis and recommend corrective and preventive actions.
Document findings, escalate critical risks, and ensure timely follow-up.
Data Analytics and Signal Interpretation
Interpret complex clinical and operational datasets to identify potential quality or safety concerns.
Advise on Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and threshold optimization.
Provide data-driven recommendations to Clinical Trial Teams and Risk Surveillance Teams.
Cross-Functional Collaboration
Act as the primary point of contact for centralized monitoring activities for assigned studies.
Participate in study team meetings as a CTT member.
Interface between Central Monitoring, Clinical Study Teams, Data Managers, and Clinical Scientific Leaders.
Ensure monitoring interventions are targeted to maximize impact on patient safety and data quality.
Compliance and Continuous Improvement
Ensure adherence to SOPs, GCP/ICH guidelines, and international regulatory standards.
Support continuous enhancement of centralized monitoring methodologies.
Contribute to knowledge-sharing and training within the Central Monitoring function.
Educational Qualifications
University degree in Life Sciences, Business, Operations, or related discipline.
Fluency in written and spoken English is mandatory.
Required Skills and Competencies
Strong understanding of clinical trial development, monitoring processes, and risk management.
Expertise in centralized monitoring, KRIs, QTLs, and RBQM frameworks.
Knowledge of global regulatory requirements and ICH-GCP standards.
Advanced analytical and critical thinking skills with the ability to interpret complex clinical datasets.
Strong communication and stakeholder management capabilities.
Ability to work cross-functionally in global, matrix-driven environments.
Why Consider This Role
Strategic involvement in global clinical trial oversight.
Exposure to innovative centralized monitoring technologies and advanced analytics.
Opportunity to shape risk-based monitoring strategy within a leading global pharmaceutical organization.
Career progression within Clinical Development and Data Surveillance.
About Novartis Healthcare Private Limited
Novartis is a global pharmaceutical organization committed to reimagining medicine through scientific innovation and patient-focused research. The company operates with a strong commitment to compliance, diversity, inclusion, and excellence in clinical development.
SEO Keywords
Central Monitor Jobs India, RBQM Specialist Hyderabad, Risk-Based Monitoring Careers, Clinical Data Surveillance Jobs, KRI QTL Monitoring, Clinical Trial Oversight Roles, Pharmaceutical R&D Jobs India, Centralized Monitoring Specialist 2026.
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