Mgr, Laboratory Operations - Clinical Trials
The Manager, Laboratory Operations for Clinical Trials manages and is accountable for all departmental operations. The Manager is responsible for all areas of analysis, clinical decision making, information management, regulatory compliance, training, quality assurance/performance improvement and departmental budgeting.
LOCATION: Rochester, NY
DEPARTMENT: Clinical Trials Laboratory Operations
SCHEDULE: Monday - Friday
- Bachelor’s degree in Medical Technology, Clinical Laboratory Science or Chemical, Physical or Biological Science required.
- 6 years of laboratory experience required.
- Previous leadership experience preferred.
- Experience in a clinical trials, clinical research setting preferred.
- Operations. Manages and is accountable for all operations of the clinical trials lab. Prepares departmental budget in conjunction with operations management, researches and makes recommendations for new capital equipment, and contracts for reagents and instrumentation. Monitors budget performance, prepares variance analysis and takes corrective action to ensure acceptable budget performance. Participates in operational meetings and conducts regularly scheduled departmental meetings. Serves on, or chairs, organizational and inter-corporate committees.
- People. Supervises and coordinates the activities of personnel to efficiently handle the day-to-day workload. Hires, transfers, promote, disciplines, and terminate employees according to existing policies. Monitors the overall performance employees. Prepares and delivers annual and interim performance evaluations and makes salary adjustments accordingly. Oversees staff in the development and evaluation of new products and procedures to increase efficiency and reduce costs.
- Quality. Comply with all regulatory requirements, such as IHC, FDA, CAP and NY state. Oversees Quality Control and Proficiency Testing processes. Provides leadership for the establishment, monitoring, and analysis of departmental QA indicators. Initiates plan of corrective action if needed. Communicates QA outcomes to appropriate individuals and departments.