Centralized Monitoring Lead

Location: India/UK/Canada

Position Summary

The Centralized Monitoring Lead is responsible for leading Risk-Based Quality Management (RBQM) and centralized monitoring activities across global medical device clinical investigations. This role partners closely with Clinical Operations, Data Management, Biostatistics, Medical Affairs, Quality Assurance, Regulatory Affairs, and Clinical Data Review teams to proactively identify risks, ensure data quality, protect subject safety, and maintain regulatory compliance throughout the study lifecycle

The individual will lead centralized monitoring activities in accordance with ISO 14155, ICH-GCP, FDA, MDR, and applicable global regulatory requirements while driving data-driven decision-making and continuous quality improvement

Key Responsibilities (but not limited to)

Risk-Based Quality Management (RBQM)

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• Lead the implementation and execution of Risk-Based Quality Management (RBQM) strategies for global medical device clinical investigations
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• Develop and maintain study-specific Risk Assessment and Categorization Tool (RACT), Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and centralized monitoring plans
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• Continuously evaluate study risks and recommend mitigation strategies
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• Lead periodic risk review meetings with cross-functional stakeholders
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Centralized Monitoring

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• Perform centralized monitoring activities using clinical, operational, safety, and quality data
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• Review data trends, protocol deviations, missing data, enrollment performance, adverse events, device deficiencies, monitoring findings, and site performance metrics
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• Identify data anomalies, outliers, fraud indicators, protocol non-compliance, and emerging risks
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• Escalate critical issues and recommend corrective and preventive actions (CAPA)
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Clinical Data Surveillance

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• Monitor
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• Enrollment and recruitment trends
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• Data entry timelines
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• Query aging
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• Protocol deviation
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• Missing data
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• Subject withdrawal
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• Device accountability
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• Adverse Events (AEs)
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• Serious Adverse Events (SAEs)
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• Device deficiencies
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• Endpoint data quality
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• Source Data Verification (SDV) strategy
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• Source Data Review (SDR
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Cross-functional Collaboration

Partner closely with

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• Clinical Operations-Clinical Monitoring
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• Data Management
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• Biostatistics
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• Medical Affairs
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• Clinical Safety
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• Regulatory Affairs
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• Quality Assurance
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• Clinical Data Review Team
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• Clinical Project Management
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Technology & Analytics

Utilize RBQM and clinical systems including

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• Medidata Detect
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• Medidata Rave
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• Oracle Clinical One
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• Veeva Vault CDM
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• SSA
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• Power BI
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• Spotfire
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• Tableau
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• CTMS
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• RBQM dashboard
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Generate centralized monitoring reports and study dashboards

Quality & Compliance

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• Ensure compliance with
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• ISO 14154
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• ICH E6(R2)/(R3)
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• FDA regulations
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• EU MD
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• Company SOPs
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• Risk-Based Monitoring methodologies
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• Support sponsor audits and regulatory inspections
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• Participate in CAPA investigations and quality improvement initiatives
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