Clinical Supply Chain Specialist
395 Oyster Point Blvd, , Suite 217 South San Francisco, CA 94080 US
The Clinical Supply Chain Specialist contract role will perform clinical supply chain activities through all stages of a clinical trial, from start-up through study close-out through successful execution of the items listed below.
This position has the potential to be fully remote. Occasional travel will be required for in person meetings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Ensure timely provision of packed and labeled investigational medicinal product (IMP) by coordinating shipping and logistics activities including management of shipments of clinical supplies between storage depots.
· Maintain reporting for inventory on-hand, consumption, movements, lot and expiry tracking for all locations where IMP inventory is stored.
· Understand, maintain, and troubleshoot the clinical supplies management functionality of IRT systems.
· Monitor clinical supply inventory levels at storage depots and interface with Clinical Operations and CMC team to maintain continuous supply availability.
· Communicate and collaborate with Clinical Operations on routine basis to understand the current and future scope clinical studies and convey the clinical supplies need to CMC for the purpose of planning future manufacturing, packaging, and labeling. Experience in use of related software tools is expected.
· Execute supply and inventory plans and tracks production schedules for clinical trial materials.
· Support outsourcing to external vendors (Contract Manufacturing Organizations (CMOs), Contract Clinical Distributors (CCDs) and Interactive Response Technology (IRT) systems) to ensure that labeling, packaging, and shipping of IMP in compliance with company SOP and applicable regulations through direct communication with the vendors.
· Coordinate obtaining approvals of technical documents such as clinical label text, clinical- packaging master batch records, clinical trial protocols and pharmacy manuals
· Provide general Clinical Manufacturing and Supply Chain support to other projects and products, as assigned
· Generation and or review of procedures as applicable to clinical supply chain operations.
· Assist in archiving of clinical supply documents.
· BA or BS in a Science or Logistics filed or equivalent experience in clinical supply
· Previous experience in the clinical supplies field required. Minimum 2 years clinical supplies experience preferred.
· Must be able to achieve deliverables with high precision.
· Ability to work independently on projects within a team-oriented environment.
· Innovative thinker with ability to solve complex problems.
· Knowledgeable and compliant to regulations and requirements for functioning under GMP, GDP, and GCP’s.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.
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