Manager, CT Specimen Management
The Manager, Clinical Trials Specimen Management is responsible for daily management and overall operations of Clinical Trials Specimen Management. Partners with the Clinical Trials Leadership team to ensure the appropriate capacity planning and resources for current & future volume. Manages performance improvement and talent management activities to drive a high quality and efficient process.
STATUS: Full Time
LOCATION: ACM Global Laboratories - Elmgrove Park
DEPARTMENT: Clinical Trials Specimen Management
- Bachelor’s Degree required OR Associates Degree + 2 years of specimen processing/sample management experience required OR 7 years of specimen processing/sample management experience required.
- 3 years of laboratory experience required; preferably in specimen processing/sample management, phlebotomy, lab assistant, etc.
- 2 years supervisory experience required.
- Documentation of completion in training of IATA shipping practices within 30 days of hire.
- Operational Management. Oversees daily management for CT Specimen Processing. Supervises and coordinates the activities of personnel to efficiently handle the day-to-day workload. Create, monitor and refine Key Performance Indicators. Regularly track KPIs and daily management metrics to ensure the appropriate capacity planning and resource allocation. Recognizes the need for and assumes bench work responsibilities when scheduled or in the case of staffing shortages. Prepares departmental budget in conjunction with operations management. Monitors budget performance, prepares variance analysis and takes corrective action to ensure acceptable budget performance. Oversees all talent management activities including but not limited to: hiring, transfers, promotion, career development and performance management. Participates in operational meetings and conducts regularly scheduled departmental meetings.
- Quality & Regulatory. Participates in and facilitates quality issue resolution including root cause analysis, etc. Strategic implementation of solutions. 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. Performs duties with a general working knowledge of CAP, FDA, NYSDOH, GCP, ICH and other pertinent regulations, as pertains to central laboratory functions. Reviews, interprets and monitors compliance with pertinent regulations/standards. Interacts with auditors as needed. Reviews departmental policies and procedures manuals to maintain regulatory compliance.
- Process Improvement. Suggests, validates and implements service improvements to ensure profitability and continued growth of the organization. Drives process improvement activities