Clinical Trials Manager (Study Manager)

Gaithersburg, MD 20878

Posted: 10/11/2018 Industry: Other Area(s) Job Number: 31917


 •             Plan and manage all aspects of Investigational Product (IP) supply for assigned clinical studies

•             Work collaboratively within Logistics and Clinical Supply (LCS) to provide seamless deliver of Vendor, Distribution and Systems management activities

•             Liaise with interfaces and stakeholders internally and externally as required to ensure highly effective clinical supply planning and execution, including on-going responsiveness to any changes that may impact supply strategy.

•             Contribute to the operational effectiveness of Logistics and Clinical Supply


*** Clinical Trials experience is a nice to have

*** PM experience in drug development is needed

*** Minimum of 3 years experience in Quality assurance & compliance background

Requires a Bachelor’ s degree in basic or applied science or engineering.

The Study Manager will have appropriate direct experience working in a development or technical operations environment in the pharmaceutical, scientific or health care product industry. Specific experience in IP management and/or supply is desirable.

•             Substantial experience in planning and managing all aspects of IMP management for clinical studies, including oversight of vendor management of GMP operations. Have a complete understanding of cGMP, GCP and ICH guidelines as related to IMP management.

•             Experience in the Biotechnology and/or Pharmaceutical industry is required and experience in IP management and supply is preferred
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