Covance External Lab Mgr in NC, United States
We are seeking an External Lab Manager for our Durham, NC site. Will be 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. This position will be responsible for the following:
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 appropriate group of the modification.
Provide support to CAIR / Reportable Issues pertaining to External laboratories, obtaining root cause and preventative actions from the referral laboratory.
Facilitates technical discussions with appropriate staff at the referral laboratories, Medical Affairs, Global Heads of Central Labs, Scientists of Central Labs, 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 External Labs topics.
Provide some support to the 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, and internal Covance Central Labs personnel.
Participate in and/or lead process improvement initiatives to drive operational efficiency.
Other duties as assigned
BS/BA degree or equivalent education certification.
Preferred Masters degree in MT/MLT.
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 Central Labs experience.
Knowledge of drug development, central laboratories
Knowledge/experience with formal process improvement discipline (eg, Six Sigma)
Job Number 2018-18308
Job Category Clinical Operations
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.