北京 [切换城市] 北京招聘

External Lab Manager

科文斯医药研发(北京)有限公司上海分公司

  • 公司规模:500-1000人
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2015-02-24
  • 工作地点:上海-浦东新区
  • 招聘人数:若干
  • 职位类别:其他  

职位描述

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


Essential Job Duties:

1. Participate to the creation and development of new the external lab model

2. 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.

3. Attend the New Test Feasibility meeting and provides information about referral laboratory options.

4. 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.

5. 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.

6. Provide support to CAIR / Reportable Issues pertaining to External laboratories, obtaining root cause and preventative actions from the referral laboratory or inside ELMS.

7. Facilitates technical discussions with appropriate staff at the referral laboratories, Medical Affairs, Global Heads of CCLS, Scientists of CCLS, Project Management and/or Sponsor asneeded to appropriately understand the client needs and the service capability of the referral laboratory.

8. Acts as the primary resource for ELMS topics.

9. Provide some support to the APH Program Manager for outsourced histology testing.

10. Accountable for the implementation, monitoring and reporting of internal and external lab performance metrics and take corrective actions when appropriate.

11. Develop and manage vendor relationships with key laboratories in order to influence positive client and Covance outcomes.

12. 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.

13. Provides technical information, both written and verbal, to Marketing, Sales, Sourcing, Project Management, WLOS and internal Covance CLS personnel.

14. Participate in and/or lead process improvement initiatives to drive operational efficiency.

15. Other duties as assigned


Required:

1. Experience in change management and influencing without authority

2. Demonstrated expertise in leading change

3. 2 years of clinical trial management, vendor management, or client relationship management

4. Preferred 2 years of CCLS experience or similar position outside Covance CLS

5. Preferred Knowledge of drug development, central laboratories

6. Preferred Grad MT/MLT, BS/BA degree , Baccalaureat or equivalent education certification.

7. Optional MD or PhD

公司介绍

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

Well come to our online job pool to dig out more opportunities at:
http://careers.covance.cn/

联系方式

  • 公司网站:http://www.covance.com
  • Email:calvin.xu@covance.com
  • 公司地址:上海市黄埔区西藏中路268号来福士广场1806室
  • 邮政编码:200001
  • 联系人:Vicky Qu