Supervisor, Clinical Trials Specimen Management

Job Title: Supervisor, Clinical Trials Specimen Management

Department: Specimen Processing

Location: Rochester, NY

Hours Per Week: 40

Schedule: Monday - Friday; 8:00 AM – 4:30 PM

SUMMARY

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.

RESPONSIBILITIES

• Perform all Specimen Management processes to a high level of quality

• Collate and report specimen management related metrics to support forecasting and decision-making, and propose strategies for improvement using these metrics

• Responsible for timekeeping and approval in KRONOS

• Assists in the maintenance and coordination of the cold storage units and environmental monitoring systems and processes as directed by Manage

• Participates in rotating schedule for “on call” environmental monitoring and response outside of regular hours

• Demonstrate initiative in professional self-development to improve relevant working knowledge of other ACM Clinical Trials departments and processes

• Actively participate in CTSM leadership group meetings to develop standardization and process excellence within the department

• Manage ad-hoc process improvement/remediation projects as required and perform other duties as assigned

• Performs duties with a general working knowledge of CAP, FDA, NYSDOH, GCP, ICH and other pertinent regulations, as pertains to central laboratory functions

• Is responsible to ensure quality driven training is provided to all staff, monitors proficiency, and performs yearly competency for all assigned staff

• Drive daily workflow in all CTSM areas through task rotation, daily team meetings, and directing team members

• 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

• Actively participate in recruitment and onboarding of new team members

• Act as a mentor and coach to CTSM team

• Serve as a  contact for, and act as departmental SME for the resolution of specimen management related issues and queries

• Participates in Quality Issue Investigations and CAPA, performs root cause analysis, and implement corrective actions

• 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

• 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

• Interact with internal clients including attending meetings as a departmental SME

• Participate as directed in Quality Audits and inspections as prescribed by departmental policies and regulatory agencies

• Guarantee client satisfaction by providing exceptional service through a consistent customer centric approach, a focus on precision delivery, and flexibility to meet customer expectations

• Back up for Manager, Specimen Management as necessary

• Courier samples between buildings 150-160 as requested

• Other duties as assigned by the manager

REQUIRED QUALIFICATIONS

• 6+ months supervisory or team lead experience is required

• Documentation of completion in training of IATA shipping practices within 30 days of hire

PREFERRED QUALIFICATIONS

• Associates Degree with concentration in Biology, Biomedical Sciences or related field

• 2 + years supervisory or team lead experience, preferred

• Clinical Trials or Biorepository Sciences experience

• Experience within laboratory or highly regulated environment

• Strong Microsoft Office and Data Entry skills

EDUCATION:

LICENSES / CERTIFICATIONS: