Clinical Supply Program Manager

2 months ago


Southeast Fairbanks, United States Parexel Full time

  • Acts as the primary point of contact with the CMO project management team to communicate trial supply requirements, initiate quotes and develop supply delivery timelines in conjunction with the CMO.
  • The Clinical Supply Program Manager (CSPM) partners with Global Clinical Supply Chain (GCSC), Clinical Operations, Quality, External Vendors and other key stakeholders to support the successful management of global clinical supplies for Phase IIV clinical trials, Investigator Initiated Research as well as Expanded Access Programs.
  • The CSPM is the primary point of contact with the Contract Manufacturing Organization (CMO) regarding the setup and execution of supply chain activities at the CMO,
including packaging, labeling, storage, distribution and returns/destruction management.

  • The CSPM partners with GCSC and other internal stakeholders to support the creation and execution of a global clinical supply plan encompassing the packaging and distribution of supplies.
  • Supports the design, set-up and operation of the Interactive Response Technology (IRT) in relation to functions regarding clinical supplies.
  • Oversees clinical supply logistical activities including site shipments, international depot shipments as well as in-transit and on-site temperature excursion management.
Qualifications:


4+ years relevant Pharmaceutical Industry related work experience required for simple to moderate complexity trials while highly complex trials require 8+ years experience.

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