Lead EDC validation for global clinical trials. ICON seeks a Senior Validation QC Analyst in Bangalore/Chennai. 8+ yrs exp in EDC systems, clinical validation & team leadership. Apply now.
Lead with Precision: Ensure Data Integrity at the Heart of Clinical Research
ICON plc is a world-leading healthcare intelligence and clinical research organization. Our mission is to accelerate the development of drugs and devices that save lives and improve quality of life through robust, reliable data.
We are seeking an expert Senior (Principal) Clinical Validation Analyst to be a cornerstone of our Data Validation team in India (Bangalore or Chennai). In this high-impact leadership role, you will be the functional authority for Electronic Data Capture (EDC) system validation across a portfolio of complex global clinical trials. Your deep expertise will ensure the highest standards of data integrity, regulatory compliance, and system quality, while you mentor the next generation of validation professionals.
Your Mission: Architect Validation Excellence
As a Senior Validation Analyst, you will define and uphold the gold standard for clinical system testing. You will be the go-to expert, leading validation strategy, solving complex challenges, and ensuring our clinical data foundations are unshakable for sponsors and regulators alike.
Key Responsibilities
1. Strategic Validation Leadership & Execution
- Serve as the Functional Lead for EDC validation across multiple, concurrent clinical studies, providing technical oversight and ensuring alignment with protocol requirements.
- Develop, author, and execute comprehensive validation strategies, plans, protocols, and test scripts to meet 21 CFR Part 11, GAMP 5, and ICH-GCP standards.
- Lead risk-based validation approaches, perform system impact assessments, and implement robust quality control measures.
2. Technical Expertise & Standards Development
- Act as the Subject Matter Expert (SME) for EDC clinical systems (e.g., Medidata Rave, Veeva, Oracle), providing authoritative guidance to project teams and junior analysts.
- Develop, maintain, and champion best practice standards for testing methodologies, documentation, and validation processes within the department.
- Stay ahead of industry trends, regulatory changes, and technological advancements in clinical data systems.
3. Team Development & Client Partnership
- Mentor and develop junior Clinical Validation Analysts, fostering a culture of technical excellence and continuous learning.
- Lead client-facing interactions, integrating seamlessly with sponsor teams to understand needs and deliver high-quality, compliant validation deliverables.
- Ensure all validation activities are thoroughly documented, maintaining an audit-ready state for regulatory inspections.
Who You Are: The Ideal Candidate
You are a seasoned validation professional who combines deep technical mastery with strategic leadership. You are a natural mentor, a persuasive communicator, and a problem-solver who is driven by ensuring impeccable quality in clinical data.
Your Required Foundation:
- 8+ years of progressive experience in clinical data validation, quality control, or systems testing within a CRO, pharmaceutical, or biotechnology setting.
- Deep, hands-on functional expertise in leading Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Veeva EDC, Oracle Inform).
- Proven experience developing validation documentation (plans, protocols, test scripts, reports) in a regulated GxP environment.
- Strong understanding of clinical trial protocols, data management processes, and regulatory requirements (ICH-GCP, 21 CFR Part 11).
- Demonstrated leadership experience – leading functional project teams, mentoring staff, and overseeing a portfolio of studies.
- Excellent problem-solving, analytical, and communication skills (written and verbal).
What Sets You Apart:
- Experience with other clinical systems (IRT, ePRO, Safety Databases) and their integration validation.
- Formal qualifications in Computer System Validation (CSV), Quality Assurance, or Software Testing.
- Proven success in a client-facing or strategic consultancy role.
- Experience contributing to internal process improvement or training initiatives.
Why Lead the Validation Team at ICON in India?
1. Impact at Scale
- Your work directly safeguards the data integrity of dozens of global clinical trials, influencing critical development decisions.
- Play a key strategic role in one of ICON’s major operational hubs in India.
2. Recognized Expertise & Career Growth
- Be recognized as a Principal-level expert and internal leader in a highly specialized field.
- Clear pathway to Managerial, Directorial, or Enterprise SME roles within Global Data Validation or Quality.
- Influence the future of validation practices and technology adoption across the organization.
3. Comprehensive Senior Benefits & Flexibility
- Highly competitive salary and performance-linked bonus.
- Choice of location with flexible hybrid working model (Bangalore or Chennai).
- Generous annual leave and company holidays.
- Premium health insurance for you and your family.
- Retirement planning benefits and financial wellness programs.
- Global Employee Assistance Programme and dedicated leadership development.
Join a Culture that Values Technical Mastery
At ICON, we believe that technical excellence is the bedrock of trust in clinical research. We are committed to creating an inclusive environment where experts can lead, innovate, and mentor.
Ready to define the standard for clinical validation excellence in India?
If you are a leader who combines deep technical skill with a passion for quality, we want to hear from you. Apply now.
