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Clinical Database Validation Analyst

IQVIA
1-2 years
Not Disclosed
Kochi, India
1 June 9, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing

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