eCOA Manager

Responsibilities

• Provide end-to-end leadership for Randomization and Trial Supply Management (RTSM/IRT) and eCOA systems
• Support the design, development, configuration, and lifecycle management of RTSM/IRT/eCOA systems
• Partner with Clinical Operations to align on scope, timelines, and deliverables for study requirements
• Develop and manage User Requirement Specifications (URS) and system design documentation
• Lead User Acceptance Testing (UAT) and ensure the completion of validation and testing documentation
• Serve as the primary operational interface between study teams, vendors, and internal functional teams
• Manage vendor deliveries, change control, and emergency system changes
• Identify process gaps and drive continuous improvement to ensure inspection readiness
• Manage user access requests, modifications, and periodic access reviews

Requirements

• Bachelor’s degree (BA/BS) required
• Minimum 5 years of operational experience in clinical trials within a pharmaceutical company or CRO
• Deep expertise in RTSM/IRT (IVRS/IWRS) and eCOA systems
• Proven experience leading User Acceptance Testing (UAT) and validation activities
• Hands-on experience with RTSM/IRT/eCOA vendor management
• Strong project management skills with experience managing complex, matrixed studies
• Excellent communication, negotiation, and stakeholder management capabilities

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.