Clinical Research Project Manager - Remote

📋 Description

• • Serve as the strategic orchestrator of life-changing clinical trials for the University of Miami’s Department of Executive Dean for Research, guiding multi-site studies from concept to close-out while ensuring every protocol advances the university’s mission to transform patient care across South Florida, Latin America, and the Caribbean.
• • Own the full project lifecycle—scope definition, resource planning, timeline creation, risk mitigation, and quality assurance—for a portfolio of complex clinical studies that span therapeutic areas such as oncology, ophthalmology, cardiology, and neurology, leveraging the world-class resources of Sylvester Comprehensive Cancer Center and Bascom Palmer Eye Institute.
• • Translate scientific objectives into executable project plans by collaborating with principal investigators, biostatisticians, regulatory affairs specialists, and central service teams; produce Gantt charts, RACI matrices, and milestone dashboards that keep cross-functional teams aligned and leadership informed.
• • Identify, track, and resolve protocol deviations, enrollment bottlenecks, and data-quality issues in real time; initiate protocol amendments, update informed-consent forms, and coordinate with IRBs and sponsors to maintain continuous regulatory compliance and participant safety.
• • Build and lead high-performing project teams—clinical research coordinators, data managers, regulatory associates, and financial analysts—by assigning clear task ownership, delivering targeted orientation sessions, and conducting regular performance reviews that uphold University of Miami and FDA standards.
• • Drive operational excellence by streamlining workflows, automating status reporting, and instituting lessons-learned sessions after each study milestone; champion a culture of continuous improvement that reduces cycle times and increases first-time-right deliverables.
• • Serve as the primary liaison between investigators and central resource services (pharmacy, imaging, laboratory, and budget offices), ensuring that contracts, CDAs, and purchase orders are executed on schedule and within budget parameters that you help negotiate and monitor.
• • Prepare and deliver executive-level presentations to deans, department chairs, and external sponsors; translate complex data into concise narratives that highlight enrollment velocity, safety signals, budget burn rates, and strategic recommendations for go/no-go decisions.
• • Mentor junior project staff and clinical research coordinators through formal training modules on GCP, HIPAA, and University of Miami policies; cultivate a pipeline of talent that sustains the university’s reputation as a top-tier academic research institution.
• • Safeguard the integrity of every study by maintaining meticulous project files in secure, audit-ready systems; ensure that source documents, regulatory binders, and financial records are inspection-ready for sponsors, IRBs, and FDA auditors at any time.
• • Champion diversity, equity, and inclusion in trial design and recruitment strategies, ensuring that under-represented populations have equitable access to cutting-edge therapies and that the university’s research reflects the communities it serves.
• • Stay ahead of evolving regulations, technology platforms, and therapeutic innovations by attending national conferences, participating in university grand rounds, and piloting new digital tools that enhance remote monitoring, e-consent, and decentralized trial capabilities.