Senior Manager, Clinical Project Management, Global Clinical Research Aortic
Core
Manage global clinical trials for transcatheter aortic heart valve replacement (TAVR) devices, ensuring regulatory compliance and data integrity for regulatory submissions.
Role type
Senior Manager, Clinical Project Management
Builds
Clinical trial deliverables and regulatory submissions for Edwards' Transcatheter Heart Valve (THV) business unit
Domain
Medical devices / Cardiovascular / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial management, Regulatory compliance (GCP), Data synthesis, Vendor management, Project planning, Risk mitigation, Team leadership, Resource allocation
Preferred skills
Master's degree, Large manufacturing experience, Clinical Trial Management System (CTMS) expertise, Electronic Trial Master File (eTMF) expertise, Regulatory submission expertise
Technologies
CTMS, eTMF, MS Office Suite
Responsibilities
Manage clinical trial activities and regulatory requirements; Synthesize clinical trial data for operational strategies; Develop and manage clinical project plans for complex trials; Lead clinical core teams in data cleaning and execution; Determine resources and set project priorities; Analyze trial performance and implement corrective actions; Oversee selection and deliverables of clinical vendors and study sites; Provide mentoring to project team members
Seniority
Senior Manager, hands-on leadership with strategic oversight
