We are seeking an External Associate Lab Manager. This can be a remote position. The External Associate Lab Manager position requires the ability to work in a global virtual environment on the tasks relative to the development and management of all external laboratory (Local Labs, Referral Labs) services contracted through Covance Central Lab Services. 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. This position will also have an emphasis on QC of ELMS documentation.
Essential Job Duties:
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.
Responsible for the QC of ELMS (Expanded Laboraotry Managment Services) documentation and processes.
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 Database setup and support (DBSS) 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 Histology testing that we send material outside Covance CLS.
Accountable for the reporting of internal performance metrics and take corrective actions when appropriate.
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, DBSS and internal Covance CLS personnel.
Bachelors degree or equivalent education
Prefer a Masters degree in MT/MLT
Prefer a background in QC of clinical materials
Experience in change management and influencing without authority
Demonstrated expertise in leading change
Knowledge of drug development, central laboratories
Knowledge/experience with formal process improvement discipline (eg, Six Sigma)