Project Manager, Clinical Research
Core
Manages planning and execution of clinical trials and research projects, specifically overseeing regulatory decisions and expanded access/compassionate use submissions for the University of Miami/UHealth.
Role type
Senior Project Manager, Clinical Research (Regulatory)
Builds
Clinical research programs and regulatory submission processes
Domain
Healthcare / Clinical Research / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project planning and scope definition, Resource allocation and timeline management, Protocol problem identification and resolution, Staff assignment and task delegation, Quality assurance and documentation, Budget and contract tracking, Regulatory compliance management, Cross-functional team coordination
Preferred skills
Knowledge of FDA/NIH regulations, Experience with electronic submission systems (Velos, IBIS), Data extraction from EMR
Technologies
Velos, IBIS, Office software
Responsibilities
Define project scope and objectives, Establish comprehensive project plans and timelines, Monitor project progress and adjust as needed, Identify and resolve protocol problems, Manage project staff and ensure orientation, Review work quality against standards, Document project activities and maintain files, Create communication schedules for stakeholders, Prepare and present status reports, Manage research budgets and disbursements, Ensure compliance with institutional SOPs and federal regulations, Coordinate expanded access/compassionate use submissions with stakeholders (IRB, FDA, etc.), Assist with adverse event reporting and clinical data extraction.
Seniority
Senior, hands-on IC
