RTSM/eCOAManager

## Accountabilities Lead the end-to-end design, configuration, and lifecycle management of RTSM/IRT and eCOA systems in alignment with clinical trial protocols and study requirements. Partner with clinical operations and cross-functional teams to define system scope, timelines, and deliverables for global studies. Develop and maintain User Requirement Specifications (URS), system design documentation, and related validation artifacts. Oversee system testing activities, including User Acceptance Testing (UAT), validation, and quality assurance documentation in compliance with regulatory standards. Serve as the primary RTSM/eCOA subject matter expert across study teams, providing guidance throughout the clinical trial lifecycle. Manage system issues, defects, and change control processes in collaboration with vendors, quality teams, and internal stakeholders. Ensure RTSM systems comply with SOPs, regulatory expectations, and audit readiness requirements, including security and access controls. Coordinate RTSM user access management, including onboarding, modifications, periodic reviews, and compliance tracking. Drive process standardization, workflow documentation, and continuous improvement initiatives across RTSM operations. Develop training materials and role-based learning programs to support system adoption and regulatory alignment. Requirements: Bachelor’s degree (BA/BS) in a scientific, healthcare, or related field. 5+ years of clinical trial experience within a pharmaceutical company and/or CRO environment. Strong expertise in RTSM/IRT (IVRS/IWRS) and eCOA systems across the clinical trial lifecycle. Proven experience managing system builds, configuration updates, and validation activities end-to-end. Hands-on experience leading User Acceptance Testing (UAT) and managing system quality processes. Experience working with RTSM/IRT/eCOA vendors and managing external partnerships. Strong project management experience in complex, matrixed global study environments.