Clinical Supply Chain Contractor

Summary:

The Clinical Supply Chain contractor be responsible for managing investigational drug supplies for one global Phase III oncology trial. They will oversee all aspects of clinical supply management including

packaging, labeling, distribution, comparator sourcing, monitoring inventory, and vendor oversight. They will have an excellent understanding of the clinical supply packaging and labeling processes and be able to independently manage supply needs and distribution.

Responsibilities:

• Develop clinical supply packaging and labeling to fulfill clinical study dosing requirements and
• patient compliance for clients upcoming global Phase III study. 
• Work with CMC, Clinical Operations, Quality Assurance, Regulatory Affairs, vendors, and others, as required, to finalize
• and implement designs.
• Work with CMO to source the comparator drugs required for this study.
• Manage outsourcing of labeling, packaging, storage, and distribution of manufactured drug supply and co-administered supplies to global sites.
• Translate clinical protocol into a supply forecast to determine the appropriate amounts of drug supply needed and schedule productions accordingly. 
• Collaborate with external vendors to develop and approve specifications and user acceptance testing of IRT system. 
• Review and request modifications when study plans change.
• Manage end to end supply chain activities including accountability and reconciliation for global trials.
• Provide timely technical review of vendor-generated documentation and collaborate with Quality to complete final review/approvals, as required.
• Collaborate with CMC, Quality, Regulatory and Clinical Operations, and others, as needed to assure joint success.
• Prevent and resolve operational issues such as deviations, corrective and preventative actions, production delays, etc.

Requirements:

• BS, MS or PharmD degree, and at least 5-7 years of clinical supply chain experience within pharma/biotech. APICS certification or coursework is desired.
• Thorough understanding of GXPs governing the manufacture of pharmaceutical drug products and conduct of routine clinical trials distribution.
• Extensive experience in clinical supply management including logistics (labeling, packaging, distribution, expiries), inventory tracking, and managing IRT systems.
• Must be knowledgeable in US, EU, and ROW clinical supply labeling requirements and the QP review/release/certification process for European clinical supplies.
• Experience with both ambient and cold chain products.