eCOA Manager

Job Summary

The RTSM/eCOA Manager is responsible for end-to-end leadership of Randomization and Trial Supply Management (RTSM/IRT) systems and eCOA in collaboration with Clinical Operations across a diverse clinical trial portfolio. This role serves as the subject matter expert (SME) and primary point of contact for RTSM activities working closely with Clinical Operations vendors and crossfunctional study teams to ensure high-quality system design delivery testing and ongoing support.

The incumbent leads RTSM system development and User Acceptance Testing (UAT) oversees vendor deliveries manages timelines and risks and ensures compliance with regulatory and quality standards. This role requires strong technical expertise project management skills and a continuous improvement mindset to maintain RTSM processes at industry bestpractice levels.

Essential Functions of the Job

• Support design development configuration and lifecycle management of RTSM/IRT/eCOA systems to meet protocol and study requirements.
• Partner with Clinical Operations and study teams to understand RTSM/IRT/eCOA requirements and ensure alignment on scope timelines and deliverables.
• Develop and manage User Requirement Specifications (URS) and system design documentation.
• Ensure completion review and filing of validation and testing documentation in accordance with quality standards.
• Provide ongoing RTSM/IRT subject matter expertise to crossfunctional study teams throughout the study lifecycle.
• Identify investigate and resolve system defects and issues in collaboration with Quality Clinical Operations and vendors on deviations.
• Manage change control and emergency system changes.
• Serve as the primary operational interface between study teams RTSM vendors and internal functional teams.
• Ensure RTSM systems and documentation comply with SOPs and applicable regulations.
• Oversee quality reviews validation documentation approval.
• Managing RTSM user access requests modifications and removals including oversight of periodic access reviews and audit readiness.
• Alignment with SOPs regulatory expectations and system security controls.
• Support the development and implement standardized RTSM processes.
• Document endtoend RTSM workflows and associated guidance.
• Identify process gaps and drive continuous improvement aligned with SOPs and regulations.
• Ensure RTSM processes support inspection readiness and consistent execution.
• Develop rolebased RTSM training curricula and materials.
• Ensure training aligns with processes system functionality and regulatory expectations.

Minimum Requirements

• Bachelors degree required (BA/BS).
• Minimum 5 years of operational experience in clinical trials within a pharmaceutical company and/or CRO.
• Strong knowledge of the clinical trial process with deep expertise in RTSM/IRT (IVRS/IWRS) eCOA systems.
• Endtoend experience managing RTSM system builds and updates.
• Proven experience leading User Acceptance Testing (UAT) and validation activities.
• Handson experience working with RTSM/IRT/eCOA vendors; vendor management experience required.
• Project management experience managing complex matrixed studies or programs.
• Familiarity with testing and issuetracking tools.
• Ability to independently identify issues analyze root causes and implement solutions in a complex environment.
• Strong communication negotiation and stakeholdermanagement skills.
• Demonstrated leadership organization and prioritization capabilities

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. Learn more at

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.