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Senior Clinical Validation Analyst

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ICON
5-8 years
Not Disclosed
Bangalore, Chennai, India
2 May 7, 2026
Job Description
Job Type: Full Time Education: Preferred Bachelor’s Degree Fields: Epidemiology Biostatistics Statistics Bioinformatics Economics Data Science Public Health Healthcare Analytics Or equivalent quantitative/scientific disciplines Skills: ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Clinical Validation Analyst

Location: Chennai, India / Bangalore, India
Work Mode: Office With Flex
Job Type: Full-Time
Experience Required: Minimum 5–8+ Years in Clinical Data Validation, Clinical Data Management, or Clinical Research
Industry: Clinical Research / Clinical Data Science / Pharmaceutical / CRO


Job Overview

We are seeking an experienced and detail-oriented Senior Clinical Validation Analyst to support clinical trial data quality and validation initiatives across global clinical research programs. The selected candidate will play a critical role in ensuring the accuracy, integrity, and regulatory compliance of clinical trial data through advanced validation methodologies and data review processes.

This role is ideal for professionals with expertise in clinical data validation, clinical data science, regulatory compliance, and validation strategy implementation within pharmaceutical, biotechnology, or CRO environments.


Key Responsibilities

Clinical Data Validation & Quality Assurance

  • Develop and execute:
    • Clinical data validation strategies
    • Validation plans
    • Data quality review processes
    • Validation methodologies
  • Ensure:
    • Accuracy of clinical trial data
    • Data consistency
    • Regulatory compliance
    • High-quality clinical deliverables
  • Support validation activities across multiple clinical studies and programs.

Clinical Data Analysis & Validation Oversight

  • Review and analyze:
    • Validation outputs
    • Clinical datasets
    • Data discrepancies
    • Quality review findings
  • Identify and resolve:
    • Data quality issues
    • Validation gaps
    • Inconsistencies in clinical trial data
  • Ensure adherence to:
    • Internal protocols
    • Regulatory standards
    • Industry best practices

Cross-Functional Collaboration

  • Collaborate with:
    • Clinical Data Management teams
    • Biostatistics teams
    • Clinical Operations
    • Data Science teams
    • Regulatory stakeholders
  • Define validation requirements and support data quality improvements throughout the clinical trial lifecycle.
  • Work closely with external partners and stakeholders to support validation activities and operational excellence.

Validation Strategy & Process Improvement

  • Provide strategic guidance on:
    • Validation methodologies
    • Clinical data review processes
    • Data integrity improvements
    • Workflow optimization
  • Recommend and implement process improvements to enhance:
    • Data reliability
    • Validation efficiency
    • Compliance standards

Stakeholder & Partner Management

  • Build and maintain effective relationships with:
    • Internal stakeholders
    • External vendors
    • Technology teams
    • Clinical research partners
  • Support organizational initiatives focused on:
    • Quality improvements
    • Validation standards
    • Clinical data excellence

Required Qualifications

Educational Qualifications

Preferred Qualification:

  • Bachelor’s Degree or Master’s Degree in:
    • Life Sciences
    • Data Science
    • Statistics
    • Biotechnology
    • Clinical Research
    • Healthcare Analytics
    • Or related scientific disciplines

Preferred Qualifications

  • Certifications in:
    • Clinical Data Management
    • Clinical Research
    • SAS Programming
    • Data Analytics
    • Regulatory Compliance
  • Additional expertise in:
    • Clinical validation tools
    • Healthcare data systems
    • Statistical analysis platforms