Clinical Supply Specialist

Job type:
Start date:
Real Staffing
South San Francisco
Published at:
flag_no USA
Project ID:

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  • Support clinical supplies activities surrounding availability of IP to study sites, including planning, forecasting of IP requirements and scheduling IP pack and label runs.
  • Manage Endpoint IRT system, monitor site compliance with inventory entries, interface with sites and troubleshoot any issues with the system.
  • Receive, review, analyze, and process study site IP replenishment orders for European sites
  • Develop and maintain Investigational Product labeling. Collaborate with Quality Assurance in developing, reviewing and approving internal documentation related to labels. Collaborate with Regulatory Affairs in regulatory reviews and approval of IP label text for multiple regions and countries.
  • Monitor IP Inventory levels per site.
  • Track inventory expiration dates.
  • Support distribution activities, including shipment to study sites, storage facilities, and IP returns. Coordinate shipment and logistics for multiple products, from raw material to commercial finished product .
  • Support Supply Chain metrics development and monthly reporting.
  • Develop, write and update departmental Standard Operating Procedures.
  • Maintain study IP documentation files
  • Participate in meetings with internal and external stakeholders as appropriate
  • Additional projects and responsibilities as required

  • Bachelor's in Operations, Materials Management, Finance, Chemistry, or a related field.

  • 5-7 years in pharmaceutical/biotech industry experience in supply chain management

Knowledge, Skills, and Abilities
  • Ability to work under time constraints and meet deadlines. Strong customer service ethic.
  • Proficient in Microsoft Outlook, Word & Excel
  • Must be highly organized and possess excellent attention to detail
  • Must have strong oral, written and interpersonal communication skills
  • Motivated, self directed, able to work autonomously and have a proven ability to work in a team environment
  • Prior experience with distribution of temperature sensitive pharmaceutical products desirable. Prior experience in developing label text for clinical studies required.

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