Job Title: Central Monitor
Location: Hyderabad, India (Office-based)
Employment Type: Full-Time
Application Deadline: February 21, 2026
Job Requisition ID: REQ-10070501
Category: Clinical Operations / Data Surveillance
The Central Monitor (CM) plays a critical role in Data Surveillance and Risk-Based Quality Management (RBQM) by providing centralized oversight of clinical trials. This position focuses on ensuring data quality, patient safety, and regulatory compliance through advanced centralized monitoring, data analytics, and risk-based monitoring strategies.
Working closely with the Risk Surveillance Lead (RSL), Clinical Trial Teams (CTTs), Data Analysts, and other cross-functional stakeholders, the Central Monitor supports early risk identification, risk assessment, and the definition and execution of Key Risk Indicators (KRIs) throughout the clinical trial lifecycle. The role serves as a key interface between centralized monitoring functions, clinical study teams, and field monitoring teams.
Centralized Monitoring Execution
Implement and execute centralized monitoring strategies aligned with study-specific Risk-Based Monitoring (RBM) plans.
Perform ongoing aggregate data surveillance using centralized monitoring technologies to identify trends, anomalies, and risk signals.
Collaborate with Data Analysts to review centralized monitoring outputs and conduct initial risk assessments.
Provide input into required data domains for centralized monitoring in accordance with monitoring strategies.
Ensure compliance with SOPs, RBM frameworks, and industry best practices.
Risk Identification and Management
Identify potential study, site, and data risks through centralized monitoring platforms in alignment with the Integrated Quality Risk Management Plan (IQRMP).
Support root cause analysis for identified risks and recommend corrective and preventive actions.
Generate, document, and summarize findings within centralized monitoring systems and lead communication of results to study teams and RSLs.
Escalate critical risks in a timely manner and support follow-up actions.
Cross-Functional Collaboration
Act as a core member of the Clinical Trial Team, providing data-driven insights and recommendations.
Serve as the single point of contact for centralized monitoring activities for assigned studies.
Develop and maintain Trial Monitoring Plans addressing both standard and trial-specific risks.
Advise on the design, optimization, and thresholds of KRIs and Quality Tolerance Limits (QTLs).
Continuous Improvement and Compliance
Contribute to the continuous improvement of centralized monitoring methodologies and tools.
Ensure adherence to GCP, ICH guidelines, regulatory requirements, and internal quality standards.
Support training, knowledge sharing, and best practice adoption within the Central Monitoring function.
Bachelor’s or Master’s degree in Life Sciences, Business, Operations, or a related discipline.
Minimum 5 years of recent experience in the pharmaceutical industry or CRO environment, with strong exposure to clinical research and clinical trial management.
At least 3 years of hands-on experience in monitoring activities (central and/or site monitoring).
Demonstrated experience with centralized monitoring, KRIs, QTLs, and risk-based monitoring methodologies.
Solid understanding of Risk-Based Quality Management (RBQM) and adaptive monitoring principles.
Strong knowledge of international clinical trial standards, including GCP, ICH guidelines, and global regulatory requirements.
Excellent analytical and critical thinking skills with the ability to interpret complex clinical and operational data.
Fluent in written and spoken English.
Clinical trial operations and data surveillance
Clinical data analytics and risk signaling
Project planning and process improvement
Budget and vendor management
Stakeholder communication and collaboration
The organization is committed to fostering an inclusive and diverse workplace that reflects the patients and communities it serves. Reasonable accommodations are available for individuals with disabilities throughout the recruitment process and during employment.
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