Senior Clinical Validation Analyst
Location: Chennai, India
Work Model: Office with Flex
Job Type: Full-Time
Job Requisition ID: JR144722
Industry: Clinical Research / Data Management
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a Senior Clinical Validation Analyst to join our Chennai team. This role is critical to ensuring the accuracy, integrity, and regulatory compliance of clinical trial data, supporting successful trial outcomes through rigorous validation and quality assurance processes.
Role Overview
As a Senior Clinical Validation Analyst, you will oversee the design, execution, and review of clinical data validation processes across studies. You will work closely with cross-functional teams, internal stakeholders, and external partners to maintain the highest standards of data quality, regulatory adherence, and operational excellence.
Key Responsibilities
Develop and implement comprehensive clinical data validation strategies to ensure accuracy, completeness, and integrity of trial data.
Execute validation plans and review results, identifying trends, discrepancies, or compliance issues.
Collaborate with clinical operations, data management, biostatistics, and project teams to address validation findings and ensure corrective actions are applied.
Provide guidance on validation methodologies, process improvements, and best practices to enhance data quality and reliability.
Maintain clear documentation of validation activities and communicate findings to stakeholders.
Mentor junior analysts, supporting their development in clinical validation practices.
Ensure all validation processes comply with ICH GCP guidelines, regulatory requirements, and internal SOPs.
Support audits, inspections, and quality assurance initiatives related to clinical data validation.
Candidate Profile
Advanced degree in Life Sciences, Data Science, Statistics, or a related field.
Minimum 5–7 years of experience in clinical data validation, clinical operations, or data management within pharmaceutical, biotech, or CRO settings.
In-depth understanding of regulatory requirements, ICH GCP, and data validation techniques.
Proficiency in clinical data validation tools, software, and systems.
Strong analytical, problem-solving, and project management skills.
Excellent communication, interpersonal, and stakeholder management skills with the ability to influence quality improvements across teams.
High attention to detail, ability to manage multiple priorities, and deliver within tight timelines.
Experience Required
At least 5–7 years of clinical research experience with significant exposure to data validation, clinical data review, and quality assurance processes.
Proven track record of managing complex validation projects and delivering high-quality, compliant results.
What ICON Offers
Competitive salary and global career growth opportunities.
Comprehensive benefits including health insurance, retirement planning, life assurance, and wellness programs.
Flexible work options with supportive office culture.
Access to global networks, professional development, and continuous learning opportunities.
Inclusive, diverse, and collaborative work environment focused on innovation and excellence.
ICON is committed to equal employment opportunities and fostering an inclusive workplace. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, disability, or other protected status.
This is a strategic opportunity for experienced clinical research professionals seeking to lead clinical data validation initiatives and ensure regulatory-compliant, high-quality trial outcomes. Apply now to advance your career with ICON.
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