Senior Clinical Study Manager (Hybrid)
Core
Lead cross-functional projects to deliver clinical research business initiatives, improve processes, and implement technology solutions for the Joint Replacement division.
Role type
Senior Clinical Study Manager (Project Leader)
Builds
Clinical research technology platforms and optimized operational workflows
Domain
Medical Devices / Clinical Research Operations
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/Agile/Six Sigma certification
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; Develop project plans and risk mitigation strategies; Drive technology platform implementation and optimization; Partner with IT and vendor teams for scalable solutions; Facilitate UAT, training, and change management; Improve efficiency through process mapping and workflow redesign; Maintain compliant documentation for audits and regulatory inspections
Seniority
Senior, hands-on IC