Senior Clinical Study Manager (Hybrid)
Core
Lead cross-functional projects to deliver clinical research business initiatives, improve operational processes, and implement technology solutions for clinical systems.
Role type
Senior Clinical Study Manager (Project Leader)
Builds
Clinical research operational workflows and technology platforms
Domain
Medical Devices / Clinical Research Operations
Deliverable
product features
Required skills
Cross-functional project leadership, process transformation, systems implementation, stakeholder engagement, risk mitigation, change management, regulatory compliance, project governance
Preferred skills
Clinical technology platform implementation (CTMS, EDC, eTMF), ISO 14155 knowledge, PMP certification, Agile, Six Sigma
Technologies
Clinical Trial Management Systems, Electronic Data Capture, Electronic Trial Master Files, Electronic Clinical Outcome Assessment tools, Quality Management Systems
Responsibilities
Lead projects from initiation to closeout ensuring milestones and budgets are met; Develop project plans, resource forecasts, and risk mitigation strategies; Drive implementation and optimization of clinical research technology platforms; Partner with business, quality, IT, and vendor teams to design scalable solutions; Facilitate user acceptance testing, training, and post-implementation support; Identify efficiency improvements through process mapping and workflow redesign; Maintain compliant documentation and support audit readiness.
Seniority
Senior, hands-on IC
