Project Manager, Clinical Research
Core
Manages the planning and execution of regulatory-related clinical trials and research projects, overseeing expanded access/compassionate use submissions and ensuring compliance with FDA, NIH, and institutional SOPs.
Role type
Senior Project Manager, Clinical Research (Regulatory)
Builds
Regulatory submissions, project plans, and compliance documentation for clinical research programs.
Domain
Healthcare / Clinical Research / Regulatory Affairs
Required skills
Project management, regulatory compliance, stakeholder coordination, budget management, protocol review, documentation management, cross-functional team leadership, problem resolution, resource planning, quality assurance.
Preferred skills
Knowledge of FDA/NIH regulations, experience with expanded access processes, proficiency in electronic submission systems (Velos, IBIS), data extraction from EMRs.
Responsibilities
Define project scope and objectives; develop comprehensive project plans and timelines; monitor project progress and adjust as needed; identify and resolve protocol problems; assign tasks to project teams; manage project staff and ensure orientation; review work quality; document project activities; create communication schedules for stakeholders; prepare status reports; manage research budgets and disbursements; oversee expanded access/compassionate use submissions; ensure compliance with institutional and federal regulations; coordinate submissions with PRMC, IRB, ORA, and FDA; maintain regulatory binders and Delegation of Authority Logs; assist with adverse event reporting; support data extraction for clinical reporting.
Seniority
Senior, hands-on IC