Company Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, medical device, and public health organizations in advancing clinical development and improving patient outcomes.
Job Details
|
Category |
Details |
|---|---|
|
Job Title |
Senior Clinical Validation Analyst (Senior CVA) |
|
Company |
ICON plc |
|
Location |
Chennai |
|
Work Mode |
Office-Based |
|
Department |
Clinical Data Validation / Clinical Data Management |
|
Industry |
Clinical Research / Pharmaceutical / Biotechnology |
|
Employment Type |
Full-Time |
|
Education Preferred |
Advanced Degree |
|
Preferred Fields |
Life Sciences, Data Science, Statistics, or Related Discipline |
Role Summary
The Senior Clinical Validation Analyst (Senior CVA) is responsible for ensuring the accuracy, consistency, and integrity of clinical trial data through comprehensive validation processes. The role involves developing validation strategies, reviewing data quality outcomes, supporting regulatory compliance, and driving continuous improvements in validation methodologies.
The position also requires close collaboration with internal teams and external stakeholders to maintain high-quality clinical data standards across clinical trials.
Key Responsibilities
1. Clinical Data Validation
Develop and execute validation strategies and plans.
Ensure:
Accuracy of clinical trial data
Data integrity
Consistency across systems and datasets
Oversee validation procedures throughout study lifecycles.
2. Data Quality Management
Identify and resolve data quality issues.
Review and analyze validation outputs and reports.
Ensure adherence to:
Regulatory standards
Internal validation protocols
Clinical data quality requirements
3. Cross-Functional Collaboration
Collaborate with:
Clinical Data Management teams
Clinical Operations
Biostatistics
Regulatory teams
External stakeholders
Define and address validation requirements across projects.
4. Validation Strategy & Process Improvement
Provide strategic guidance on:
Validation methodologies
Data review techniques
Process improvements
Drive initiatives to improve data reliability and operational efficiency.
5. Stakeholder & Partner Management
Build and maintain strong relationships with:
External partners
Vendors
Internal stakeholders
Support implementation of best practices in clinical data validation.
Required Qualifications
Educational Requirements
Advanced Degree in:
Life Sciences
Data Science
Statistics
Related field
Experience Requirements
Extensive experience in:
Clinical data validation
Clinical data management
Clinical research operations
Experience managing complex validation projects.
Technical & Functional Skills
Expertise Areas
Clinical data validation methodologies
Data quality management
Clinical trial data review
Validation strategy development
Regulatory compliance standards
Tools & Systems
Data analysis tools
Validation software and systems
Clinical data management platforms
Regulatory Knowledge
Strong understanding of:
Regulatory requirements
Clinical trial standards
Data integrity principles
Industry best practices
Soft Skills
Strong analytical and problem-solving skills
Stakeholder management abilities
Excellent communication and interpersonal skills
Strategic thinking capability
Ability to influence quality improvements
Attention to detail and organizational skills
Preferred Candidate Profile
Ideal candidates may have experience in:
Clinical Data Validation
Clinical Data Management
Data Quality Assurance
Clinical Trial Data Review
Regulatory Compliance
Risk-Based Validation
Data Governance
Clinical Research
CRO environments
Pharmaceutical or Biotechnology industries
Benefits Offered
Compensation & Rewards
Competitive salary package
Recognition and performance programs
Health & Wellbeing
Comprehensive health insurance options
Employee Assistance Programme (TELUS Health)
Life assurance coverage
Wellness initiatives
Work-Life Balance
Annual leave entitlements
Flexible employee benefits
Family-focused support policies
Financial & Lifestyle Benefits
Retirement planning programs
Childcare vouchers
Bike purchase schemes
Discounted gym memberships
Subsidized travel passes
Health assessments
Diversity & Inclusion
ICON plc is committed to maintaining an inclusive and accessible workplace and provides equal employment opportunities regardless of:
Race
Religion
Gender
Sexual orientation
Gender identity
National origin
Disability
Veteran status
Reasonable accommodations are available during the recruitment and employment process.
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Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
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Frank Scottile Blvd |Missouri :
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Mexico |northeastern :
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Germany | GErmany |Lower Saxony :
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Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Brinny | Ringaskiddy |Carlow :
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Galway |County Dublin :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | North York | Australia | Renfrew | Uxbridge | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
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Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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Italy |Lombardy :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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Sofia |Sweden :
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Taipei |Mazovia :
Warsaw |
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