Clinical Supply Specialist / Planner

CLINICAL SUPPLY SPECIALIST / PLANNER 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, Google Cloud Platform, 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: ALPHA'S REQUIREMENT #22-03253 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE