Associate Clinical DB Validation Manager
Location: Thāne, India
Job Type: Full Time
Job ID: R1473775
Job Description
IQVIA is seeking an Associate Clinical DB Validation Manager to manage the end-to-end delivery of database validation services for clinical research projects. This role involves providing leadership and expertise in database testing, ensuring high-quality deliverables on time and within budget. The position will require compliance with Good Clinical Practices (GCPs), regulatory guidelines, and relevant company policies.
Key Responsibilities
Project Meetings: Attend Kick Off Meetings and regular project meetings until study go-live.
Test Plan Creation: Take full responsibility for creating Edit Checks Test Plans and writing corresponding test cases.
Test Execution: Release the Edit Checks Test Plan to the testing team and oversee testing activities.
Project Management: Review the project plan and escalate any issues to all relevant stakeholders.
Protocol Review: Comprehend the study protocol and share the basic requirements with the validation project team.
Data Quality Checks: Perform eCRF and Time & Events QC as per the QC checklist.
Document Review: Review ASB and Edit Specifications documents, provide input, and escalate issues when necessary.
Version History Management: Document any changes to Edit Specifications within the Test Plan during the validation process.
Resource Management: Ensure the appropriate resources are assigned to meet project deliverables, and work with functional managers on resource planning.
Quality Management: Implement proactive quality management plans across multiple projects. Track service performance, identify root causes of issues, and take remedial actions.
Process Improvement: Look for opportunities to improve processes and drive change across projects.
Compliance Issues: Ensure timely resolution of compliance issues.
Subject Matter Expertise: Serve as a Subject Matter Expert (SME) for the validation group.
Team Training: Mentor and train Testing Team Members.
Risk Management: Identify project risks, plan for deliverables, and escalate risks to the manager.
Budget Management: Review the QIP for budget allocation and ensure adherence to study budgets.
New Technology: Supervise the implementation of new technology.
Internal Communication: Act as the primary point of contact for internal customers on testing deliverables.
Customer Relationships: Develop and maintain strong relationships with internal customers and negotiate timelines, finances, and resources as needed.
Qualifications
Education: Bachelor’s Degree in Science, Computer Science, Information Technology, or Bachelor in Technology (Required).
Experience: 4-6 years of relevant clinical DB Testing experience in CDMS Platforms with a total experience of 6+ years (Required).
About IQVIA
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. We work to accelerate the development and commercialization of innovative medical treatments, improving patient outcomes and population health globally.
Location: Thāne, India
Worker Type: Full Time
IQVIA is an equal opportunity employer, committed to diversity and inclusion.
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