Lab Manager - 251587
10 hours ago
Miami
Looking for a Strong Lab Manager to join our Clinical Research team! Must Have: • Minimum of one (1) year of experience in an early-phase clinical research laboratory; additional experience strongly preferred., • State of Florida Supervisor License in all areas of testing performed. Must be: Certification of Supervisor in Chemistry, Hematology and Serology. (all 3) Responsibilities: • Lead the build-out, start-up, and day-to-day operation of a CLIA-certified and GLP-compliant clinical research safety laboratory., • Direct and coordinate laboratory personnel to ensure quality, accuracy, and timeliness of laboratory testing and reporting., • Ensure compliance with CLIA, GLP, GCP, IRB requirements, SOPs, OSHA standards, and applicable regulatory requirements at all times., • Support CLIA and accreditation readiness activities, including inspections, audits, and corrective actions as needed., • Oversee quality control, quality assurance, and proficiency testing programs., • Develop, write, implement, and maintain laboratory SOPs, procedure manuals, and quality documentation., • Manage laboratory testing menus, including evaluation of new assays, validation planning, and coordination with reference laboratories when appropriate., • Serve as a key laboratory point of contact for sponsors and internal clinical teams, including participation in study initiation meetings., • Coordinate sample processing, storage, and shipment in accordance with protocol and sponsor requirements., • Oversee laboratory supply management, inventory control, and equipment maintenance., • Manage, mentor, and evaluate laboratory staff, including performance management and timekeeping as applicable., • Ensure accurate and timely electronic data transfers and laboratory data reporting to sponsors when required., • Maintain a safe, organized, and inspection-ready laboratory environment.