Associate Director – Clinical Supply Chain
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Job Description
Lead end-to-end clinical supply chain operations for international studies at Codera, ensuring compliance and timely delivery of clinical materials. Oversee key supply chain vendors and support study strategies.
Responsibilities:
- Lead end-to-end clinical supply chain operations for assigned international studies
- Serve as the primary clinical supply chain contact for assigned studies
- Provide study- and site-level operational support, including resupply requests facilitation, returns and destruction oversight, and temperature excursion management
- Develop and execute global inventory supply plans in coordination with Technical Operations, Clinical Operations and Quality Assurance
- Lead label development efforts for assigned studies, including booklet label development for international studies
- Manage manual and IRT-enabled drug supply shipments
- Facilitate and oversee storage, returns, reconciliation and destruction
- Monitor inventory levels, drug product expirations and resupplies
- Oversee import/export licenses and customs forms
- Ensure batch release dates are properly prioritized for key study timelines
- Review and approve packaging and labeling documents and batch records
- Prepare and manage clinical supply projections
- Maintain budget for supply chain operations for assigned studies and review and track monthly invoices from vendors against budget
- Ensure clinical supply documentation is organized and filed to the Trial Master File (TMF), per SOPs
- Participate in inspection readiness efforts, ensuring clinical supply chain is prepared for qualifications
Requirements:
- Bachelor’s Degree required
- Minimum 6 years of experience in clinical supply management and logistics within pharmaceutical industry required
- Experience with EU/international clinical studies required
- Experience with clinical blinding practices in clinical studies preferred
- Proficient in GxP and pharmaceutical industry procedures and regulations
- Understanding of systems selection, design and management
- Strong organizational skills with the ability to manage projects, resources, timelines and budgets, in a fast-paced environment
- Must be proficient in Microsoft Excel
Benefits:
- employer sponsored insurance plans including medical, dental and vision coverage
- generous paid time off
- retirement plan options
- additional wellness and professional development programs
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