Clin DB Validation Manager
Location: Kochi, India / Bangalore, India
Employment Type: Full Time
Job Overview
The Clinical Database Validation Manager serves as the Single Point of Contact (SPOC) and Subject Matter Expert (SME) for validation activities across Electronic Data Capture (EDC) and Clinical Data Management Systems (CDMS). The role is responsible for overseeing database validation activities, project planning, quality reviews, customer interactions, audit readiness, resource management, and ensuring compliance with regulatory and organizational standards.
This position plays a key role in supporting customer audits, internal quality audits, project delivery, and validation excellence across multiple clinical studies.
Key Responsibilities
Clinical Database Validation Leadership
Act as the primary SME for validation activities across all supported EDC platforms.
Provide technical leadership and guidance to validation teams.
Ensure validation deliverables meet project timelines, quality standards, and regulatory requirements.
Serve as the primary point of contact for internal stakeholders regarding validation activities.
Project Planning & Oversight
Attend Kick-Off Meetings (KOMs) and project meetings through study go-live.
Review project plans and identify potential risks, issues, or delays.
Escalate project concerns to relevant stakeholders when required.
Review:
Application Specification Documents (ASB/ALS)
Edit Check Specifications
Validation Requirements
Ensure validation activities align with project scope and study requirements.
Validation & Testing Management
Oversee end-to-end testing and validation activities for clinical databases.
Ensure appropriate test coverage and validation documentation.
Monitor validation progress and provide regular status updates to:
Data Team Leads
Lead Programmers
Project Stakeholders
Participate in Project Review Meetings (PRMs).
Conduct quality reviews of validation deliverables.
Audit & Compliance Support
Support and represent the validation function during:
Customer Audits
Internal QA Audits
Regulatory Inspections
Ensure validation documentation is audit-ready.
Perform periodic reviews of project documentation stored in eTMF.
Ensure compliance with:
GCP Guidelines
Regulatory Requirements
Internal SOPs
Validation Standards
Resource & Team Management
Provide project management support for validation teams.
Manage:
Resource Planning
Workload Allocation
Deliverable Tracking
Risk Identification
Train and mentor testing and validation team members.
Conduct knowledge-sharing sessions across functional teams.
Support capability development and continuous learning initiatives.
Financial & Operational Management
Review project financial performance related to validation activities.
Ensure adherence to approved study budgets.
Review Quality Impact Plans (QIP) and User Productivity Tracking (UPT).
Identify and communicate any out-of-scope activities.
Participate in discussions involving:
Timelines
Resource Allocation
Budget Impacts
Process Improvements
Customer & Stakeholder Management
Develop and maintain strong internal customer relationships.
Act as primary contact for validation-related deliverables.
Support negotiations regarding:
Timelines
Resource Requirements
Financial Implications
Process Changes
Ensure effective communication across project teams and stakeholders.
Continuous Improvement
Lead and support process improvement initiatives.
Promote best practices within validation and testing functions.
Drive standardization and quality enhancement efforts.
Contribute to organizational knowledge-sharing and innovation programs.
Qualifications
Education
Bachelor's Degree in:
Science
Computer Science
Information Technology
Engineering (B.Tech)
Related Technical Discipline
Experience (Minimum Required)
Total experience of 8+ years.
Minimum 6–8 years of Clinical Database Testing and Validation experience.
Strong experience working with:
Clinical Data Management Systems (CDMS)
Electronic Data Capture (EDC) Platforms
Clinical Database Validation Processes
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