The External Lab Manager position requires the ability to work in a global virtual team on the tasks relative to the development and management of all external laboratory (Local Labs, Referral Labs) services contracted through Covance CCLS. This position will serve as liaison on a global basis between external laboratories, internal Covance departments, and clients regarding external laboratory management services to ensure successful clinical trial delivery.
• Participate to the creation and development of new the external lab model
• Responsible for managing the overall current process of the referral laboratories by researching potential referral laboratories based on the assay requests, contacting referral laboratories, negotiating services, and acting as the liaison for operational issues/needs of the customer.
• Attend the New Test Feasibility meeting and provides information about referral laboratory options.
• Based on New Test Feasibility meeting decision, contact and completes the referral laboratory worksheets and obtains the appropriate technical information needed to load the database, including but not limited to specimen collection requirements, reference ranges, turn around time, and regulatory requirements such as Research Use Only assays.
• Recipient of notification of changes in assays such as method changes from the referral laboratories. Updates referral laboratory worksheets and notifies WLOS of the modification.
• Provide support to CAIR / Reportable Issues pertaining to External laboratories, obtaining root cause and preventative actions from the referral laboratory or inside ELMS.
• Facilitates technical discussions with appropriate staff at the referral laboratories, Medical Affairs, Global Heads of CCLS, Scientists of CCLS, Project Management and/or Sponsor as needed to appropriately understand the client needs and the service capability of the referral laboratory.
• Acts as the primary resource for ELMS topics.
• Provide some support to the APH Program Manager for outsourced histology testing.
• Accountable for the implementation, monitoring and reporting of internal and external lab performance metrics and take corrective actions when appropriate.
• Develop and manage vendor relationships with key laboratories in order to influence positive client and Covance outcomes.
• Responsible for maintaining his/her complete up-to-date training file. Individual is responsible for ensuring he/she is trained and training is documented prior to performing a task. Individual is accountable for any deficiencies found in his/her training file.
• Provides technical information, both written and verbal, to Marketing, Sales, Sourcing, Project Management, WLOS and internal Covance CLS personnel.
• Participate in and/or lead process improvement initiatives to drive operational efficiency.
• Other duties as assigned
Preferred Grad MT/MLT, BS/BA degree , Baccalaureat or equivalent education certification.
Optional MD or PhD
• Experience in change management and influencing without authority
• Demonstrated expertise in leading change
• 2 years of clinical trial management, vendor management, or client relationship management
• 2 years of CCLS experience or similar position outside Covance CLS
• Knowledge of drug development, central laboratories
• Knowledge/experience with formal process improvement discipline (eg, Six Sigma)