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Clinical Supply Specialist / Planner

Watertown, MA

Posted: 12/12/2022 Job Number: 22581477

Job Description

100% Remote.
TOP 3 " Must Haves "
  • Knowledge of IRT.
  • Ability to model in Excel.
  • Knowledge of clinical labeling/packaging operations.

Project Description:
  • Client is seeking a talented, independent, and highly motivated Clinical Supply Chain Manager with expertise in supply chain management to join our Pharmaceutical Sciences group.
  • Responsible for day-to-day activities related to managing the supply of Clinical Trial Material (CTM) through all stages of clinical development including packaging, labeling, and distribution.
  • This role will also support and advise Clinical Operations, Regulatory, Quality, and clinical sites on all aspects of CTM and comparator products as applicable.
  • Support clinical supply activities for on-going and new clinical trials for on-time delivery, including demand forecasting, trial monitoring & resupply planning, IRT set-up and distribution activities.
  • Design and execute packaging and labelling campaign activities including but not limited to; timeline management, documentation approval, and coordination with Contract Development and Manufacturing Organizations (CDMO).
  • Support management of Contract Development and Manufacturing Organizations (CDMO) and provide comprehensive information about clinical supplies.
  • Ensure continuous supply of clinical trial material for ongoing studies within the US and ex-US locations.
  • Ensure on time startup of new studies by having supplies available as required.
  • Manage and track manual on-time distribution to US and ex-US clinical sites.
  • Develop efficient process and tracking report for manual shipments.
  • Review clinical protocols and design appropriate supply chain strategy.
  • Oversee a variety of logistics issues, including but not limited to supply chain services, inventory control, import-export, shipment of products and third-party warehousing.
  • Act as liaison for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight and scope review related to clinical supplies.
  • Drive timelines of requested bulk manufacturing, packaging, labeling and final release to meet forecasted demand.
  • Develop, maintain and present Clinical Supply Chain dashboard to be shared with upper management.
  • Establish and maintain process with Accounts Payable and Legal to effectively manage on-time approvals of purchase orders, change orders and invoices of Contract Development and Manufacturing Organizations (CDMO).
  • Work collaboratively and transparently with Clinical Operations, Technical Sciences, Quality Assurance and Regulatory Affairs.

Required Skills:
  • BS degree with 3-5 years' experience in a Supply Chain Planning role in a Biotechnology or Pharmaceutical environment.
  • Must Have Knowledge of IRT, Ability to model in Excel, Knowledge of clinical labeling/packaging operations.
  • Excellent project management, organizational and communication skills.
  • Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient.
  • Thorough understanding of regulatory requirements for clinical supply distribution in US, APAC, and EU including testing and labeling requirements is a plus.
  • Experience in cold-chain clinical supply distribution is a plus.
  • Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials.
  • Experience working with QP, IRTs, depots with global IP distribution.
  • Project Management Professional certification is a plus.
  • Experience managing contract packaging and labeling organizations (strongly preferred).
  • Experience in pediatric packaging and labeling requirements is a plus.
  • Periodic travel to manufacturing and other partner sites is required (approximately 10% of time), in accordance with applicable COVID-related travel guidelines.

This 6+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com


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Bridget Burns

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