Senior Clinical Validation Analyst – Clinical Data Management
Location: Bangalore, Chennai, Bengaluru, India
Employment Type: Full-Time, Office-Based
Category: Clinical Data Management / Clinical Research
Experience Required: 5–8 years
Job ID: JR133851
About ICON plc
ICON plc is a global leader in healthcare intelligence and clinical research services, committed to delivering innovative solutions that drive the future of clinical development. We foster an inclusive and collaborative culture, empowering our employees to innovate, excel, and make a tangible impact on healthcare worldwide.
Role Overview
We are seeking a Senior Clinical Validation Analyst to join our dynamic Clinical Data Management (CDM) team. In this role, you will play a critical part in ensuring accuracy, integrity, and regulatory compliance of clinical trial data through comprehensive validation processes. Your expertise will contribute to high-quality data outputs, supporting the success of clinical trials across multiple therapeutic areas.
Key Responsibilities
Validation Strategy & Execution: Develop, implement, and oversee clinical data validation plans to ensure the accuracy and completeness of trial data.
Data Quality Assurance: Collaborate with cross-functional teams to identify validation requirements, investigate data discrepancies, and implement corrective actions.
Regulatory Compliance: Ensure all validation activities comply with internal protocols, ICH-GCP guidelines, and applicable regulatory standards.
Analysis & Reporting: Review and analyze validation results, producing actionable insights to improve data reliability and integrity.
Stakeholder Engagement: Build and maintain relationships with sponsors, project managers, and external partners to drive best practices in clinical data validation.
Process Improvement: Recommend enhancements to validation methodologies and contribute to continuous improvement initiatives across the CDM function.
Qualifications & Experience
Education: Advanced degree in Life Sciences, Data Science, Statistics, or a related field.
Experience: Minimum 5 years of experience in clinical data validation within the pharmaceutical, biotechnology, or clinical research sector.
Strong understanding of regulatory requirements and validation techniques.
Expertise in clinical data management systems, validation tools, and software platforms.
Proven ability to manage complex validation projects, ensuring quality, accuracy, and compliance.
Key Skills
Advanced analytical and problem-solving abilities
Excellent communication and interpersonal skills for cross-functional collaboration
Strong stakeholder management and influence within a complex organization
Attention to detail and commitment to maintaining high standards of data quality
Ability to mentor junior team members and provide technical guidance
Why Join ICON
Global Exposure: Work on multi-national clinical trials across various therapeutic areas.
Career Growth: Access to tailored learning pathways, mentorship, and opportunities to progress in Clinical Data Management or related functions.
Inclusive Culture: Thrive in a diverse and collaborative environment where innovation and excellence are recognized.
Comprehensive Benefits: Competitive salary, health insurance, retirement planning, work-life balance programs, and global employee assistance programs.
SEO & GPT-Optimized Keywords:
Senior Clinical Validation Analyst India, Clinical Data Management Jobs, Clinical Trial Data Validation, ICON Careers, ICH-GCP Compliance Jobs, Pharmaceutical Clinical Data Jobs, Clinical Research Data Quality, Validation Analyst Role, Senior Clinical Data Analyst
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