Clinical Database Validation Analyst
Location: Kochi, India
Job Type: Full-Time
Application Deadline: July 1, 2026
Job Requisition ID: R1533603
About the Role
We are seeking a detail-oriented Clinical Database Validation Analyst to support the testing and validation of clinical databases within Clinical Data Management Systems (CDMS). The successful candidate will be responsible for conducting comprehensive testing activities, validating database functionality, ensuring compliance with quality standards, and contributing to the delivery of reliable and efficient clinical data solutions.
This role offers the opportunity to work with industry-leading EDC/CDMS platforms while collaborating with global clinical data management and database development teams.
Key Responsibilities
Clinical Database Testing & Validation
Independently perform testing activities within Clinical Data Management Systems (CDMS).
Validate:
Edit Checks
System Settings
SAS Listings
Data Transfer Programs
Custom Reports
Ensure all database components function according to study requirements and specifications.
CDMS Platform Expertise
Conduct testing and validation activities across industry-standard platforms, including:
Oracle InForm
Medidata Rave
Oracle Clinical Remote Data Capture (OC-RDC)
Other supported EDC/CDMS systems as required
Database Quality Assurance
Verify database configurations and functionality against design specifications.
Ensure database validation processes comply with internal quality standards and best practices.
Perform ongoing quality reviews of testing projects.
Identify and document defects, inconsistencies, and validation issues.
Documentation & Compliance
Maintain complete and accurate testing documentation.
Update validation records and project documentation in a timely manner.
Ensure adherence to:
Standard Operating Procedures (SOPs)
Work Instructions
Validation Guidelines
Best Practice Documents
Support audit readiness through proper documentation management.
Project Coordination & Communication
Communicate project status, risks, and progress updates to Validation Leads and Managers.
Escalate issues that may impact project quality, timelines, or deliverables.
Support successful project execution by meeting assigned objectives and deadlines.
Mentorship & Team Support
Provide guidance and support to Associate Validation Analysts.
Mentor junior team members on testing methodologies and validation processes.
Share best practices and technical knowledge across the team.
Continuous Improvement
Identify opportunities to improve validation processes and testing efficiency.
Participate in process improvement initiatives and quality enhancement projects.
Contribute ideas to optimize database testing standards and workflows.
Cross-Functional Collaboration
Build effective working relationships with:
Clinical Data Management Teams
Database Design Teams
Programming Teams
Validation Teams
Global Project Stakeholders
Collaborate across multiple locations and functional groups to support project success.
Required Qualifications
Education
Bachelor’s Degree in one of the following disciplines:
Computer Science
Information Technology
Life Sciences
Biotechnology
Engineering (B.Tech)
Related Technical or Scientific Field
Experience
Required
1–2 years of hands-on Clinical Database Testing or Validation experience.
Minimum 2+ years of overall professional experience.
Experience working within Clinical Data Management Systems (CDMS).
Preferred
Experience validating clinical databases for clinical trials.
Exposure to regulated clinical research environments.
Familiarity with end-to-end database development lifecycle.
Technical Skills
Clinical Data Management Systems
Experience working with one or more of the following platforms:
Oracle InForm
Medidata Rave
Oracle Clinical RDC (OC-RDC)
Other EDC/CDMS Platforms
Validation & Testing
Database Validation
Functional Testing
User Acceptance Testing (UAT)
Edit Check Validation
Data Transfer Validation
Report Validation
Defect Tracking and Resolution
Database Knowledge
Strong understanding of database structures and relationships.
Ability to review and validate database configurations.
Understanding of data collection and clinical data workflows.
Preferred Knowledge
Clinical Trial Processes
Clinical Data Management (CDM)
Electronic Data Capture (EDC) Systems
Good Clinical Practice (GCP)
Clinical Database Design Lifecycle
Regulatory Compliance Requirements
Quality Management Systems
Key Competencies
Attention to Detail
Analytical Thinking
Problem Solving
Quality Focus
Technical Documentation
Time Management
Communication Skills
Team Collaboration
Process Improvement
Mentoring & Knowledge Sharing
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