Senior Clinical Validation Analyst
Location: Bangalore / Chennai / Bengaluru, India
Job ID: JR133851
Department: Clinical Data Management
Work Model: Office-Based
Industry: Clinical Research / CRO / Healthcare Intelligence
Job Overview
A leading global clinical research organization is hiring a Senior Clinical Validation Analyst (CVA) to join its Clinical Data Management team in India. This role is critical in ensuring the accuracy, integrity, and regulatory compliance of clinical trial data through comprehensive validation processes.
The ideal candidate will bring deep expertise in clinical data validation, regulatory standards (FDA, ICH-GCP), and quality assurance methodologies within the clinical research industry.
This position is based in Chennai, Bangalore, or Bengaluru, offering the opportunity to work on global clinical trials across therapeutic areas.
Key Responsibilities
Develop and execute clinical data validation strategies and validation plans aligned with study protocols and regulatory requirements.
Ensure the accuracy, consistency, and completeness of clinical trial datasets.
Review, analyze, and interpret validation outputs to maintain compliance with FDA, ICH-GCP, and global regulatory standards.
Collaborate with cross-functional teams including Clinical Data Managers, Biostatisticians, Clinical Operations, and IT.
Identify data discrepancies and implement corrective and preventive actions (CAPA).
Provide strategic input to improve validation methodologies and enhance overall data reliability.
Support audit readiness and regulatory inspections by maintaining proper validation documentation.
Contribute to process improvement initiatives within Clinical Data Management.
Required Experience
Minimum 5–8 years of experience in clinical data validation, clinical data management, or related roles within a CRO, pharmaceutical, or biotech environment.
Demonstrated experience with clinical trial data review and validation processes.
Strong understanding of regulatory requirements including FDA guidelines, ICH-GCP, and global compliance standards.
Hands-on experience with clinical data management systems (CDMS), EDC platforms, and validation tools.
Proven ability to manage complex validation projects in a matrix environment.
Educational Qualifications
Master’s degree or advanced qualification in Life Sciences, Pharmacy, Biotechnology, Statistics, Data Science, or a related field.
Equivalent experience in clinical data validation may also be considered.
Core Competencies
Advanced analytical and problem-solving skills
Expertise in clinical data validation methodologies
Strong stakeholder management and communication skills
Ability to drive quality improvements and process optimization
High attention to detail and regulatory compliance mindset
Why Join
The organization offers a competitive compensation package along with comprehensive employee benefits designed to support professional growth, financial planning, and overall well-being. Benefits may include:
Competitive salary structure
Health insurance coverage
Retirement and savings plans
Employee Assistance Programs
Life assurance coverage
Flexible benefit options based on country policies
Work-life balance initiatives
The employer is committed to diversity, equity, inclusion, and maintaining a workplace free from discrimination.
Equal Opportunity Statement
All qualified applicants will receive equal consideration for employment without regard to race, religion, gender, sexual orientation, disability status, or protected veteran status. Reasonable accommodations are available for candidates with medical conditions or disabilities.
Keywords for Search Optimization:
Senior Clinical Validation Analyst Jobs India, Clinical Data Validation Careers, Clinical Data Management Jobs Bangalore, CRO Jobs India, FDA Compliance Clinical Data, ICH-GCP Validation Roles, Clinical Research Jobs Chennai, Pharma Data Validation Careers
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