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External Lab Mgr

Covance 3/28/2018 7:09:58 AM
JOB ID: 18308 Category: Clinical Operations
Durham, North Carolina

   

 

Job Overview

This position will work remotely. We are seeking an External Lab Manager to 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

Education/Qualifications

BS/BA degree or equivalent education certification.

Preferred Masters degree in MT/MLT.

Experience

Minimum Required:

* 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

Preferred:
- 2 years of Central Labs Experience .
- Knowledge of drug development, central laboratories
- Knowledge/Experience with formal process improvement discipline (eg, Six Sigma)

* Genomics Experience or Histology Experience preferred.


Position Type: Full-Time

Location: Durham, NC - North Carolina



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).