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Associate Director, Clinical Supply Chain - CONTRACT

  • 0 yrs
  • $ Not Disclosed / YEAR

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Job Description

Overview


Scope


The Associate Director, Clinical Supply Chain will oversee all aspects of clinical supply management including forecasting, packaging, labeling, distribution, monitoring inventory, and vendor oversight.


Responsibilities


Key Responsibilities



  • Develop and manage forecasts by creating and reviewing clinical supply demand for clinical trials

  • Work closely with Technical Operations and Clinical Operations teams to ensure timely labeling, packaging and distribution of clinical trial material

  • Ensure continuity of supply by establishing and monitoring an appropriate monthly forward inventory level and advising Clinical Operations team and study sites on inventory levels throughout the trials

  • Identify potential supply risks and develop preventive actions to avoid supply interruptions

  • Collaborate with external vendors to develop and approve specifications and user acceptance testing of IVR/IWR systems, while reviewing and modifying when study plans change

  • Review vendor-generated documentation and collaborate with Quality team to complete final review/approvals

  • Manage vendors and their respective contracts, invoice review, and budget planning

  • Establish workflows and SOPs in accordance with industry best practices


Qualifications


Experience and Qualifications



  • A degree in natural science, engineering, nosiness administration

  • A minimum of 6 years of clinical supply chain experience including phase I & II clinical trials. APICS certification or coursework is preferred

  • Direct experience in planning and overseeing supply for double-blinded placebo-controlled, as well as open label clinical studies

  • Forecast and manage supply needs and distribution

  • Knowledge of global practices governing pharmaceutical drug product manufacturing and conduct of routine clinical trials distribution

  • Clinical supply management including forecasting, labeling, packaging, distribution, expiries, inventory tracking, and managing IRT systems

  • Knowledge of US, EU, and rest of the world clinical supply labeling requirements is required. Knowledge of QP review process for European clinical supplies is preferred

  • Experience with both ambient and cold chain products is preferred