AACC Career Center

Manager, Specimen Kit Services

Spotlight Preferred
CTI Clinical Trial Services
Cincinnati, Ohio, United States
13 days ago

Description

Manager, Specimen Kit Services
 
Job Purpose / Summary: The Manager, Specimen Kit Services is responsible for development and management of a specimen kit building department, including kit development, tracking, inventory management and compliance.  

What You'll Do
  • Develop and implement work processes and SOPs for a Global Specimen Kit Building Department
  • Work closely with Project Managers (PMs) and other laboratory personnel to fulfill study specific kit building, delivery, tracking and oversight
  • Supervise and perform Quality Control (QC) checks on laboratory kit specification documents
  • Attend meetings for the hand-off of projects and assists with project-specific training of internal staff
  • Tertiary project contact with Sponsors and Contract Research Organizations to ensure appropriate communication channels are maintained and reporting schedules adhered to
  • Collaborate with PMs with protocol amendments and change control documentation
  • As needed, interfaces with laboratory(ies), BD, Operations, and Data Management to communicate study needs or for problem-solving
  • Assist with collection of PRM quality and performance-related metrics to assess the success of study oversight activities
  • Manage requests for shipment of stored samples as directed in the SOW, and coordinate with Biorepository staff to ensure samples are shipped on time
  • Create training materials for investigator meetings as applicable
  • Assist PM in study closure activities including working with Quality and Regulatory Services in archiving study documents after study close
  • Oversee processes to maintain applicable supplies required for project needs
What You'll Bring
  • BS in biological science, clinical laboratory science, medical technology, or another relevant field – or related experience
  • 3-5 years of Laboratory experience in a production environment
  • 2+ years of supervisory experience, including laboratory personnel and equipment
  • Experience in maintaining inventory or resources in an organized manner
  • Experience in using PC, printer, bar code labels & scanner or document scanner
  • Experience with quality and process improvement projects
  • Proven ability to manage timelines and adhere to budgetary requirements
Why CTI?
  • We support career progression –  We have a structured mentoring program to provide the support you need to move forward
  • We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
  • We value our people - We have never had a layoff in our 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decade
  • Our culture is unparalleled – We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
  • We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to improve their local communities (click here to learn more about our “CTI Cares” program)
  • We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate (a recent report found that the average turnover for CROs in the US was 30%)
  • Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market!


Requirements

Required Education and Experience:

  • BS in biological science, clinical laboratory science, medical technology, or another relevant field – or related experience
  • 3-5 years of Laboratory experience in a production environment
  • 2+ years of supervisory experience, including laboratory personnel and equipment
  • Experience in maintaining inventory or resources in an organized manner
  • Experience in using PC, printer, bar code labels & scanner or document scanner
  • Experience with quality and process improvement projects
  • Proven ability to manage timelines and adhere to budgetary requirements

Preferred Education and Experience:

  • 3 years’ experience managing specimen kit building
  • Experience with high volume laboratory operations
  • Experience with Laboratory Information Management System (LIMS)
  • Working knowledge of GCP, GLP and federal and local regulations

Job Information

  • Job ID: 57163655
  • Location:
    Cincinnati, Ohio, United States
  • Position Title: Manager, Specimen Kit Services
  • Company Name: CTI Clinical Trial Services
  • Discipline: Academic / Research
  • Job Function: Lab Manager
  • Work Setting: Independent Medical / Diagnostic Laboratory
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: BA/BS/Undergraduate
  • Min Experience: 3-5 Years
  • Required Travel: 0-10%

Please refer to the company's website or job descriptions to learn more about them.

View Full Profile

Jobs You May Like