Senior Manager, Clinical Systems

Role Summary

The Senior Manager of Clinical Systems serves as the clinical systems manager and technical lead for clinical technology initiatives. This position is responsible for the oversight, planning, and execution of end-to-end clinical system processes from start up through archival. This role combines clinical systems expertise with strong technical project management capabilities, ensuring successful delivery of system implementations, integrations, and enhancements.

This position will provide technical and business management in support of system compliance and inspection readiness, while driving structured execution of cross-functional initiatives. The role requires strong collaboration across Clinical, IT, Quality, and external vendors to manage timelines, risks, dependencies, and change management activities. This position will also lead efforts to define requirements, promote adoption of processes and standards, act as a point of escalation and ensure alignment with company goals, culture, and vision.

Key Responsibilities

• Provide clinical system guidance as a Subject Matter Expert (SME) for clinical system operations and requirements across study team functions, CROs, and vendors.
• Lead and manage clinical system programs and projects end-to-end, including scope definition, planning, timeline management, resource coordination, and execution tracking.
• Manage and support clinical system (insourced and outsourced) related projects, with a focus on IRT, site portals, CTMS and eCOA, acting as a project/program manager.
• Establish and maintain project governance, including risk management, issue tracking, dependency management, and executive status reporting.
• Build and maintain collaborative relationships with cross-functional partners, CROs, and external vendors to ensure expectations are clear, deliverables are met, and issues are resolved in a timely manner.
• Translate business and clinical requirements into technical specifications, ensuring alignment with IT, validation, and vendor capabilities.