Job Title: Associate Clinical DB Validation Manager
Company: IQVIA
Location: Kochi, India
Job Type: Full-time
Job ID: R1473775
Job Overview:
Responsible for managing validation projects for clinical databases, ensuring quality deliverables are produced on time and within budget. Provides leadership, planning, and oversight to testing teams while ensuring compliance with regulatory guidelines, SOPs, and CDM processes.
Key Responsibilities:
Project Oversight & Planning:
Attend Kick-Off and regular project meetings until Study Go Live
Own and manage the creation of the Edit Checks Test Plan
Assign and review test cases for validation
Review project plan and escalate any issues
Ensure documentation updates (e.g., Test Plans, ASB, Edit Specifications) are recorded and version-controlled
Technical & Quality Oversight:
Test email alerts, validate system configuration (AUL, Rights/Roles, etc.)
Ensure eCRF and Time & Events QC per checklist
Review Testing Comments Log and provide feedback to programmers
Monitor documentation compliance in eDMSF
Stakeholder Management:
Coordinate with internal stakeholders and functional managers to ensure proper resourcing
Provide validation status updates to Data Team Leads and Lead Programmers
Serve as the main point of contact for internal customers regarding validation deliverables
Leadership & Strategic Initiatives:
Lead and mentor validation team members
Manage project financials, budgets, and track out-of-scope activities
Conduct quality reviews and implement quality management plans
Contribute to continuous improvement processes and technological implementation
Act as Subject Matter Expert (SME) within the validation group
Qualifications:
Degree: Bachelor’s in Science, Computer Science, Information Technology, or Technology (Required)
Experience:
4–6 years of relevant clinical database testing experience on CDMS platforms
Total experience: 6+ years (Required)
Key Skills:
Clinical Data Management Systems (CDMS)
Test planning and execution
eCRF validation, edit check creation, and system configuration
Project and stakeholder management
Budgeting and financial tracking
Documentation compliance and audit readiness
Team mentoring and process improvement
About IQVIA:
IQVIA is a global leader in clinical research services, real-world data analytics, and technology solutions for the life sciences industry. Their mission is to drive healthcare forward by combining deep industry expertise with innovative technology.
🔗 Learn more at IQVIA Careers
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