RTSM/eCOA Manager in United States at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a RTSM/eCOA Manager based in the United States.

This role is a key operational and technical leadership position within clinical trial systems, responsible for the end-to-end management of RTSM/IRT and eCOA platforms supporting global studies. You will act as the primary subject matter expert, ensuring that system design, configuration, validation, and execution align with protocol requirements and regulatory standards. The role involves close collaboration with clinical operations teams, vendors, and cross-functional stakeholders to deliver high-quality, inspection-ready systems. You will oversee system lifecycle activities including requirements definition, testing, issue resolution, and continuous improvement initiatives. The environment is highly collaborative and matrixed, requiring strong coordination across global study teams and external partners. This is an impactful role at the intersection of clinical operations, technology, and process excellence in clinical research.

• 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.

• 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.
• Familiarity with issue tracking tools and clinical systems validation processes.
• Strong analytical skills with the ability to identify root causes and implement effective solutions.
• Excellent communication, stakeholder management, and leadership abilities in cross-functional settings.

• Competitive base salary with performance-based incentives.
• Comprehensive health coverage including medical, dental, and vision plans (depending on eligibility).
• Retirement and pension savings plans.
• Life assurance and disability coverage.
• Employee assistance programs and wellbeing resources.
• Structured learning and professional development opportunities.
• Exposure to global clinical trials and cutting-edge clinical technology systems.
• Inclusive and supportive work environment focused on collaboration and career growth.