Clinical Validation Analyst
Company: ICON plc
Location: Chennai / Bengaluru / Trivandrum, India
Department: Clinical Data Management & Clinical Validation
Job Type: Full-Time
Work Mode: Office With Flex (Hybrid)
JOB OVERVIEW
The Clinical Validation Analyst is responsible for ensuring the accuracy, integrity, and quality of clinical trial data through comprehensive validation activities. The role involves performing edit check testing, validating backend listings, identifying and resolving data discrepancies, developing validation documentation, and collaborating with cross-functional clinical research teams to ensure compliance with regulatory standards and clinical data management best practices.
KEY RESPONSIBILITIES
Clinical Data Validation
Perform clinical trial data validation and quality assurance activities.
Execute edit check testing and backend listing validation.
Validate clinical databases for accuracy and completeness.
Ensure data integrity throughout the clinical trial lifecycle.
Verify compliance with study protocols and validation requirements.
Data Quality Management
Identify data discrepancies and inconsistencies.
Investigate and resolve data quality issues.
Perform root cause analysis for validation findings.
Recommend corrective and preventive actions.
Maintain high standards of clinical data quality.
Validation Documentation
Develop and maintain validation plans.
Prepare validation protocols and reports.
Document validation findings and resolutions.
Maintain audit-ready validation documentation.
Support inspection and regulatory documentation requirements.
Cross-Functional Collaboration
Collaborate with Clinical Data Management teams.
Work closely with Clinical Operations and Biostatistics teams.
Coordinate validation activities with project stakeholders.
Participate in study planning and validation discussions.
Support project deliverables within established timelines.
Compliance & Regulatory Support
Ensure compliance with ICH-GCP guidelines.
Follow company SOPs and validation procedures.
Stay updated with regulatory requirements and industry standards.
Support quality audits and inspections.
Promote continuous process improvement initiatives.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in:
Life Sciences
Statistics
Computer Science
Biotechnology
Pharmacy
Biostatistics
Or a related discipline
EXPERIENCE REQUIREMENTS
Required
Minimum 2 years of experience in:
Clinical Data Validation
Clinical Data Management
Edit Check Testing
Backend Listing Validation
Clinical Research
Preferred
Experience with clinical data management systems.
Knowledge of statistical software and validation tools.
Experience working in CRO or pharmaceutical environments.
Understanding of ICH-GCP and regulatory requirements.
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