eCOA Manager

IQVIA•Durham, NC

About The Position

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 cross‑functional 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 best‑practice levels.

Requirements

Bachelor’s 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.
End‑to‑end experience managing RTSM system builds and updates.
Proven experience leading User Acceptance Testing (UAT) and validation activities.
Hands‑on experience working with RTSM/IRT/eCOA vendors; vendor management experience required.
Project management experience managing complex, matrixed studies or programs.
Familiarity with testing and issue‑tracking tools.
Ability to independently identify issues, analyze root causes, and implement solutions in a complex environment.
Strong communication, negotiation, and stakeholder‑management skills.
Demonstrated leadership, organization, and prioritization capabilities.

Responsibilities

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 cross‑functional 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 end‑to‑end 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 role‑based RTSM training curricula and materials.
Ensure training aligns with processes, system functionality, and regulatory expectations.