DATA SURVEILLANCE ANALYST
Company: Parexel
Location: Remote (India)
Department: Clinical Trials / Risk-Based Quality Management (RBQM)
Job Type: Full-Time
JOB OVERVIEW
The Data Surveillance Analyst (DSA) supports Risk-Based Quality Management (RBQM) activities by analyzing clinical trial data, identifying quality risks, monitoring Key Risk Indicators (KRIs), and conducting centralized monitoring reviews. The role focuses on ensuring data integrity, patient safety, protocol compliance, and inspection readiness through proactive surveillance and statistical analysis of clinical trial data.
KEY RESPONSIBILITIES
Data Surveillance Plan (DSP) Development
Support creation of Data Surveillance Plans (DSPs).
Define and configure:
Key Risk Indicators (KRIs)
Quality Tolerance Limits (QTLs)
Central Statistical Monitoring parameters
Support risk-based monitoring strategy development.
Technology Configuration & Management
Configure and maintain Data Surveillance platforms such as:
CluePoints Central Monitoring Platform
Create data import mappings from multiple clinical data sources.
Set up standard and customized KRIs.
Configure statistical analysis parameters and surveillance rules.
Centralized Monitoring & Data Review
Perform centralized monitoring reviews according to DSP requirements.
Review clinical and operational data for:
Data quality trends
Outliers
Site performance issues
Protocol deviations
Emerging risks
Evaluate Quality Tolerance Limits (QTLs).
Identify atypical data patterns requiring investigation.
Risk Detection & Escalation
Identify:
Data quality issues
Compliance concerns
Enrollment anomalies
Safety signals
Site performance risks
Escalate critical findings to project leadership.
Recommend corrective and preventive actions.
Documentation & Reporting
Document findings in:
Data Surveillance Findings Forms
CluePoints Issue Management System
Issue Tracking Systems
Prepare Central Monitoring Reports.
Maintain audit-ready documentation.
Cross-Functional Collaboration
Participate in:
Data Surveillance Review Meetings
Investigator Meetings
Sponsor Meetings
Internal Audits
Regulatory Inspections
Collaborate with:
Clinical Operations
Data Management
Biostatistics
Medical Monitoring Teams
Technology Teams
Signal Detection & Trend Analysis
Correlate findings from multiple data sources.
Analyze trends and patterns affecting:
Data integrity
Patient safety
Trial quality
Support decision-making through risk-based recommendations.
Compliance & Quality Management
Ensure compliance with:
ICH-GCP Guidelines
RBQM Principles
Sponsor Requirements
Parexel SOPs
Global Regulatory Standards
Support inspection readiness activities.
REQUIRED SKILLS
Clinical Research Skills
Risk-Based Quality Management (RBQM)
Centralized Monitoring
Data Driven Monitoring (DDM)
Clinical Data Review
Clinical Trial Operations
Quality Risk Management
Signal Detection
Data Analysis Skills
Data Trend Analysis
Outlier Detection
Root Cause Analysis
Risk Assessment
Statistical Data Interpretation
Data Visualization
Technical Skills
CluePoints Platform
CTMS (Clinical Trial Management System)
EDMS (Electronic Document Management System)
Microsoft Excel
Microsoft Office Suite
Basic SAS Programming
Clinical Data Systems
Clinical Data Knowledge
SDTM Domains
Clinical Data Operations
Data Reconciliation
Quality Tolerance Limits (QTLs)
Key Risk Indicators (KRIs)
EDUCATIONAL QUALIFICATIONS
Preferred
Bachelor's Degree in:
Life Sciences
Pharmacy
Biotechnology
Clinical Research
Statistics
Biostatistics
Preferred Advanced Degrees
M.Sc.
M.Pharm
MBA Healthcare
Clinical Research Certifications
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Queensland |Melbourne :
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