Clinical Trials Manager (Study Manager)
25 W. Watkins Road Ã¢ÂÂ 403A Gaithersburg, MD 20878
CLINICAL TRIALS MANAGER/ STUDY MANAGER-
• 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