Clinical Risk Analyst Manager
Location: Hyderabad, India
Work Type: On-Site
Department: Clinical Development
Position Summary
The Clinical Risk Analyst Manager is responsible for generating and translating study-level risk insights to support proactive, data-driven decision-making throughout the clinical trial lifecycle. This role plays a critical part in Risk-Based Quality Management (RBQM) by leveraging centralized monitoring, advanced analytics, and cross-functional data sources to identify, assess, monitor, and mitigate risks related to patient safety, data integrity, regulatory compliance, and study delivery.
The position collaborates closely with Study Delivery Teams, Central Monitors, Clinical Operations, and Risk Management leadership to drive structured risk reviews, implement mitigation strategies, and support portfolio-level risk oversight.
Key Responsibilities
Risk-Based Quality Management (RBQM)
Lead and support Risk-Based Quality Management (RBQM) activities across assigned clinical studies.
Drive proactive identification, assessment, and management of study risks.
Ensure risk management processes align with study objectives, regulatory expectations, and quality standards.
Support continuous improvement of RBQM methodologies and frameworks.
Centralized Monitoring & Risk Detection
Lead centralized monitoring reviews using platforms such as CluePoints.
Perform:
Risk Identification
Signal Detection
Trend Analysis
Risk Evaluation
Structured Decision-Making
Assess study data to identify emerging operational, quality, and compliance risks.
Distinguish meaningful risk signals from normal study variability.
Key Risk Indicators (KRIs) & Quality Tolerance Limits (QTLs)
Define, implement, and maintain:
Key Risk Indicators (KRIs)
Quality Tolerance Limits (QTLs)
Establish thresholds, triggers, escalation pathways, and monitoring criteria.
Continuously evaluate and optimize KRIs and QTLs to improve predictive performance and operational value.
Monitor risk metrics throughout the study lifecycle.
Study Risk Assessment & Planning
Provide expert input during Study Risk Assessments (SRAs).
Contribute to the development of Integrated Data Review Plans (IDRPs).
Support study startup activities by identifying critical-to-quality factors and associated risks.
Develop risk review strategies aligned with protocol and program requirements.
Risk Analysis & Root Cause Investigation
Analyze centralized monitoring outputs using clinical and operational context.
Investigate identified risks and determine underlying causes.
Lead Root Cause Analysis (RCA) activities for significant or recurring issues.
Assess effectiveness of mitigation actions and corrective measures.
Support development of Corrective and Preventive Actions (CAPA).
Risk Mitigation & Issue Management
Drive accountability for risk mitigation across study teams.
Ensure risk mitigation plans are:
Clearly Defined
Appropriately Assigned
Tracked to Completion
Monitor implementation and effectiveness of mitigation actions.
Escalate critical risks and issues when required.
Risk Reporting & Communication
Develop and communicate the evolving study risk profile.
Present risk insights, trends, and mitigation effectiveness to:
Study Delivery Teams
Functional Leaders
Process Owners
Risk Management Leadership
Translate complex risk data into actionable recommendations.
Support informed decision-making through clear and concise reporting.
Portfolio Risk Oversight
Collaborate with Associate Directors of Risk Management and senior stakeholders.
Ensure study-level risks contribute to broader program and portfolio-level risk management.
Support aggregation of risk signals across multiple studies.
Provide structured summaries, trend analyses, and escalation reports.
Identify recurring patterns and systemic risks impacting study delivery.
Quality Oversight & Governance
Perform quality review of centralized monitoring outputs.
Apply sampling and quality control methodologies to ensure:
Accuracy
Consistency
Reliability
Regulatory Compliance
Ensure risk decisions, actions, and outcomes are appropriately documented.
Support governance reviews, audits, and inspection readiness activities.
Documentation & Compliance
Maintain complete and accurate documentation of:
Risk Assessments
Signals and Actions
Monitoring Reviews
Escalations
Mitigation Plans
Ensure traceability within:
CluePoints
Signal & Action Trackers
Trial Master File (TMF)
Other Clinical Systems
Adhere to applicable SOPs, regulatory requirements, and quality standards.
Basic Qualifications
Candidates must meet one of the following requirements:
Doctorate Degree, OR
Master's Degree with 8+ years of clinical operations execution experience.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Canada |Quebec :
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Japan | Saitama |Tokyo :
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South Africa | Midrand |Nišava District :
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