Clinical Supplies Associate

San Francisco, CA or Cambridge, UK | Technical Operations

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Job Description

Job Summary

Support Clinical Supply Chain Managers to ensure clinical, transitional and research supplies and materials are prepared and distributed on time to support Clovis Oncology’s clinical programs. All applicable documentation received is processed and filed appropriately.  Duties involve, but are not limited to, supply chain services, inventory control, and import/export licensing activities for the shipment of clinical supply materials.

Job Responsibilities

  • Support scheduled labelling & packing operations for clinical studies and named patient programs by reviewing, verifying & filing documentation.
  • Coordinate distribution of Investigational product to depots and sites for clinical studies and named patient programs.
  • Coordinate development of product labels for clinical supplies including development of master label text and subsequent reviews and approvals.
  • Coordinate and process documentation for expiry updates of Investigational products.
  • Coordinate investigational product orders and labelling operations for Named Patient programs.
  • Process the investigation of applicable deviations at sites and during shipments with Quality group as needed.
  • Coordinate depot shipments, track and follow up on receipt and release to ensure supplies available to sites.
  • Assists with monitoring and maintaining IWRS and runs reports from IWRS to provide weekly drug projection summary data.
  • Verifies status of clinical study enrollment, depots inventories and at sites to monitor drug supply with demand.
  • Supports processing, and filing of over-labelling documentation.
  • Tracks shipments and lot retest dates to ensure timely product release and receipt.
  • Supports maintaining and archiving documents related to Import licensing and all other supply related documents from an administrative perspective.
  • Attends and is responsible for generating, maintaining and archiving of Supply Chain meeting / or related meeting minutes.
  • Supports activities related to the CMO, as assigned.
  • Other logistic activities, as assigned.
  • Follows policies, procedures and material control systems
  • Ensures compliance with Good Manufacturing Practices (GMP) and applicable state and federal regulatory authorities
  • Minimal travel may be required.

Skills & Requirements

Qualifications

  • Organizes and prioritizes numerous tasks and completes them under time constraints
  • Multitasking over cross functional groups and concurrent projects
  • Understanding of area of specialization, Clinical Supplies or Materials Management
  • Clear oral and written communication skills
  • Familiar with Microsoft office, Excel in particular; IVRS/IWRS knowledge is key
  • Works on problems of diverse scope in which analysis of data is required
  • Works well in a dynamic  working environment

Education and Experience

Education:

  • BS/BA degree in related discipline and/or two years of related industry experience; or,
  • May require certification in assigned area. CSCP Certification preferred

Experience:

  • Typically requires a minimum of two years of related experience and/or combination of experience and education/training.
  • Knowledge of GxPs and particularly GMPs.
  • Knowledge in supply chain, planning or materials management, inventory management, eSystems and business process facilitation.

Working Conditions

  • Office-based position with minimal travel required.