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Associate Director – Clinical Supply Chain
CoderaLead 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.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- employer sponsored insurance plans including medical, dental and vision coverage
- generous paid time off
- retirement plan options
- additional wellness and professional development programs
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical Supply ManagementLogisticsInventory ManagementLabel DevelopmentBatch Release ManagementClinical Supply ProjectionsGxP ComplianceClinical Blinding PracticesBudget ManagementSOP Documentation
Soft Skills
Organizational SkillsProject ManagementResource ManagementTimeline ManagementCommunication Skills