Clinical Database Validation Specialist (CDMS)
📍 Location: Kochi, India (Hybrid)
📄 Requisition ID: R1506100
🕒 Job Type: Full-time
🌐 Additional Locations: Bengaluru, India | India
About the Role
The Clinical Database Validation Specialist is responsible for executing comprehensive validation and testing activities within clinical data management systems (CDMS). This role ensures that clinical databases meet quality, accuracy, and compliance standards, contributing directly to successful study delivery and customer satisfaction.
Key Responsibilities
1. Database Validation & Testing
Perform independent validation of:
Edit checks
System settings
SAS listings
Data transfer programming
Custom reports across multiple CDMS platforms such as InForm, RAVE, and Oracle Clinical RDC (OCRDC).
Ensure strict adherence to validation processes and best practice guidelines.
Maintain a strong understanding of database architecture and data flow.
2. Documentation & Compliance
Prepare, maintain, and update all validation-related documentation in compliance with SOPs and timelines.
Ensure all testing deliverables align with Good Clinical Practice (GCP) and regulatory standards.
Support audit readiness by maintaining transparent, accurate validation records.
3. Communication & Collaboration
Provide regular project updates to the Validation Team Lead/Manager.
Proactively escalate issues, risks, or deviations in a timely manner.
Collaborate effectively with cross-functional teams across locations to ensure consistent data quality and project delivery.
4. Mentorship & Quality Review
Mentor Associate Validation Analysts in testing and validation activities.
Conduct quality reviews of validation deliverables to ensure adherence to defined standards.
Support knowledge sharing and continuous skill enhancement within the team.
5. Continuous Improvement
Identify opportunities to enhance testing efficiency and accuracy.
Actively contribute to process improvement initiatives and standardization efforts within the validation group.
Ensure full compliance with operating procedures, work instructions, and best practice guidelines.
Qualifications
Required:
Bachelor’s degree in Science, Computer Science, Information Technology, or Technology-related field.
2+ years of total experience, including 1–2 years of hands-on clinical database testing/validation within CDMS platforms (e.g., RAVE, InForm, OCRDC).
Strong understanding of clinical database structures, validation methodologies, and quality documentation practices.
Excellent communication, problem-solving, and organizational skills.
Ability to work independently while maintaining strong collaboration across teams.
Preferred Skills (Good to Have):
Knowledge of GCP, clinical data standards (CDISC, SDTM), and clinical trial lifecycle.
Familiarity with SAS programming or SQL-based database validation.
Experience in automation or process optimization within CDMS environments.
About IQVIA
IQVIA is a global leader in clinical research, real-world data analytics, and life sciences consulting. Through advanced technologies and deep healthcare expertise, IQVIA accelerates the development and commercialization of innovative therapies to improve patient outcomes worldwide.
🌐 Learn more at https://jobs.iqvia.com
How to Apply
🔗 Apply Now: IQVIA Careers – Clinical Database Validation Specialist
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