Director, Central Labs Logistics & Program Management
Exton, PA (Corporate)
Job Title: Director of Central Lab Logistics and Program Management
A job design should be utilized to ensure that candidates are evaluated against position-specific criteria. Candidates do not necessarily have to possess all of the items listed on the job design, but the goal should be for a chosen candidate to have 80% of the stated criteria.
List the key responsibilities of the position below. Interview questions should be designed to verify that the candidate has the required experience to perform the required job duties.
• The Director of Central Lab Logistics and Program Management will be building and overseeing the following critical function within the central lab
• Clinical Trial Study Setup
• Clinical Trial Project Managements
• Clinical Trial Data Analysis
• Clinical Trial Data Customer Interface
• Global Logistics and Kits Building Process
• Study set-up: Ensure appropriate and comprehensive information are in the Global Laboratory Specifications document (GLSD) and Laboratory Manual; coordinate standardized set-up process across protocols and departments to ensure studies are delivered on-time, on-budget and as contracted.
• Logistics: Responsible for test kits build for the clinical trial sites leveraging internal and external resources
• Client Management: Provide engaging and responsive client services from GLSD sign-off to the completion of the study; guarantee client satisfaction by providing exceptional service through a consistent customer centric approach
• Develop the database design requirements which include configuration (project specific kit contents, laboratory events, requisitions, and medical reports), programming for full protocols and protocol amendments, and developing and maintaining client design standards as applicable.
• Deliver accurate and timely study data
• Identify and resolve issues/requests in a timely manner per service and metric guidelines
• Setting up and following Standard Operating Procedures for day-to-day operation change control, and communication.
• Maintain a general working knowledge of FDA, Pennsylvania Department of Health, Good Clinical Practice (GCP), ICH and other pertinent regulations.
• Minimum of 3 years’ experience of clinical trial test setup, logistics, project management, and process improvement experience in a global clinical trial laboratory setting
ESSENTIAL PERSONALITY/LEADERSHIP SKILLS include the following.
The personality traits/leadership skills listed below are representative of those that are required to perform this job successfully. Interview questions should be designed to verify/validate that the candidate possesses the personality/leadership skills specified below.
• High level of accountability with self and others
• Hands-on approach with a desire to teach others
• Track record of challenging the status quo
• Team and action-oriented
• Priority setting
• Timely decisions