The Supervisor, Clinical Trials Specimen Management (CTSM) supervises a team dedicated to the timely receipt, processing, storage and shipping of Clinical Trials client specimens. The supervisor monitors employees’ performance, supports the CTSM process and ensures department turnaround times (TAT). The supervisor is also responsible for supporting regulatory compliance, quality assurance/performance improvement, and continuous improvement of CTSM processes

STATUS: Full-time

LOCATION: 150 Elmgrove Park

DEPARTMENT: Specimen Processing

SCHEDULE: Days

ATTRIBUTES

• Associates Degree with concentration in Biology, Biomedical Sciences or related field
• 1 year supervisory or team lead experience is required
• Clinical Trials or Biorepository Sciences experience
• Experience within laboratory or highly regulated environment
• Strong Microsoft Office and Data Entry skills

RESPONSIBILITIES

• Operations Management Assists in the maintenance and coordination of the cold storage units and environmental monitoring systems and processes as directed by Manager. Participate in rotating schedule for “on-call” environmental monitoring and response outside of regular hours. Drive daily workflow in all CTSM areas through task rotation, daily team meetings, and directing team members. Actively work with appropriate stakeholders on the generation of study documentation including GLSDs, requisition forms, and study protocols on behalf of CTSM to support optimal set up and running of clinical trials studies. Courier samples between buildings 150-160 as requested
• Leadership Excellence Actively participate in CTSM leadership group meetings to develop standardization and process. Promote positive working relationships with internal clients including Project Management, Study Support teams, and other key stakeholders. Be responsible for line management of CTSM personnel including performance appraisals and disciplinary processes. Responsible for timekeeping and approval in Kronos Actively participate in recruitment and onboarding of new team members. Act as a member and coach to CTSM team. Back up for Manager, Specimen Management as necessary.
• Process Improvement Collate and report specimen management related metrics to support forecasting and decision-making, and propose strategies for improvement using these metrics. Demonstrate initiative in professional self-development to improve relevant working knowledge of other ACM Clinical Trials departments and processes. Manage ad-hoc process improvement/remediation projects as required and perform other duties as assigned. Serve as a contact for, and act as departmental SME for the resolution of specimen management related issues and queries. Drive process improvement within the CTSM team by supporting operational excellence and process improvements to improve productivity, service, quality, cost savings, policies and procedures. Assist in the development and review of Standard Operating Procedures and Associated training.
• Quality & Regulatory Responsible to ensure quality driven training is provided to all staff, monitors proficiency, and performs yearly competency for all assigned staff. Participate in Quality Issue Investigations and CAPA, performs recruit cause analysis, and implement corrective actions. Participate as directed in Quality Audits and inspections as prescribed by departmental policies and regulatory agencies.