Job Description

Education and Experience:

• A minimum BA/BS in Science, Engineering, Pharmacy, or other Allied Health professions.
• A minimum of 3 years’ experience in Medical Device clinical trials, pharmaceutical, biotechnology or related firm, including direct exposure to the process of clinical study supply (IUO and Ancillary) management and execution.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• Collaborate with the Clinical Study team to include Medical Affairs, Clinical Product Management and other departments as required.
• Develop clear and efficient study product secondary labeling and packaging designs to facilitate study execution, protocol compliance, and product accountability.
• Responsible for researching products/potential vendors, researching/procuring study supplies, monitoring inbound shipments and cost accruals per study.
• Maintain Study Product and Study Supply inventory using Inventory management database.
• Inspect Study Product, including packaging and labeling per SOP and Study-specific requirements.
• Accountable for assembly of kits, formatting and printing labels, over-labelling.

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