Clinical Database Validation Manager
Locations: Kochi, India | Bangalore, India
Job Type: Full-Time
Application Deadline: June 30, 2026
Job Requisition ID: R1533246
About the Role
We are seeking an experienced Clinical Database Validation Manager to lead validation activities across clinical database platforms and serve as the primary Subject Matter Expert (SME) for database testing and validation processes.
In this role, you will oversee end-to-end validation project delivery, provide technical leadership across Electronic Data Capture (EDC) platforms, support regulatory and quality audits, manage stakeholder relationships, and ensure the successful execution of clinical database validation activities in compliance with quality standards and project timelines.
The ideal candidate will possess extensive experience in Clinical Database Testing, Validation Management, Clinical Data Management Systems (CDMS), and cross-functional project leadership within a clinical research environment.
Key Responsibilities
Validation Leadership & Technical Oversight
Serve as the primary Subject Matter Expert (SME) for clinical database validation activities across all supported EDC/CDMS platforms.
Provide technical guidance and strategic direction to validation teams.
Ensure validation methodologies, standards, and best practices are consistently applied across projects.
Support resolution of complex technical and operational challenges.
Project Management & Delivery
Manage end-to-end validation activities from study initiation through study go-live.
Attend project Kick-Off Meetings and ongoing project review meetings.
Review project plans and identify potential risks, dependencies, and resource requirements.
Ensure timely completion of validation deliverables while maintaining quality standards.
Escalate project issues and risks to stakeholders and leadership when necessary.
Validation Documentation Review
Review and assess key study documentation, including:
Application Specification Build (ASB)
Application Lifecycle Specifications (ALS)
Edit Specification Documents
Quality Improvement Plans (QIP)
User Performance Testing (UPT) Documentation
Provide recommendations and identify gaps impacting validation activities.
Ensure documentation aligns with project requirements and regulatory expectations.
Quality & Compliance Management
Conduct quality reviews of validation deliverables and project documentation.
Ensure adherence to:
Standard Operating Procedures (SOPs)
Validation Standards
Internal Quality Processes
Regulatory Compliance Requirements
Perform periodic reviews of critical study documentation within the Electronic Trial Master File (eTMF).
Lead efforts to maintain audit readiness across validation projects.
Audit & Inspection Support
Play a key role in:
Customer Audits
Internal Quality Assurance Audits
Process Reviews
Compliance Assessments
Represent the validation function during audits and inspections.
Address audit findings and implement corrective actions where required.
Resource & Financial Management
Oversee validation resource planning and allocation.
Manage project workloads and deliverable scheduling.
Monitor project budgets and validation-related financial performance.
Review budget utilization and communicate potential issues to stakeholders.
Ensure adherence to approved study budgets and resource plans.
Stakeholder Management
Act as the primary point of contact for internal stakeholders regarding validation deliverables.
Collaborate closely with:
Data Management Teams
Database Design Teams
Programming Teams
Project Managers
Clinical Operations Teams
Provide regular project status updates and participate in Project Review Meetings (PRMs).
Customer Relationship Management
Develop and maintain strong relationships with internal and external customers.
Negotiate timelines, resources, deliverables, and process requirements when necessary.
Communicate project expectations and validation strategies effectively.
Ensure customer satisfaction through high-quality service delivery.
Team Leadership & Mentorship
Train, mentor, and develop validation team members.
Conduct knowledge-sharing sessions across departments and functional groups.
Promote continuous learning and technical excellence within the team.
Support career development and performance improvement initiatives.
Continuous Improvement
Identify opportunities to improve validation processes, testing efficiency, and quality standards.
Drive implementation of process enhancements and best practices.
Support organizational initiatives focused on operational excellence and innovation.
Required Qualifications
Education
Bachelor’s Degree in one of the following disciplines:
Computer Science
Information Technology
Life Sciences
Biotechnology
Engineering (B.Tech)
Related Scientific or Technical Field
Experience
Required
6–8 years of hands-on Clinical Database Testing and Validation experience.
Minimum 8+ years of total professional experience.
Extensive experience working with Clinical Data Management Systems (CDMS) and Electronic Data Capture (EDC) platforms.
Proven experience leading validation teams and managing multiple projects simultaneously.
Uttar Pradesh :
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