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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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
The ideal candidate must demonstrate strong leadership in managing clinical supply chain operations while ensuring compliance with industry regulations. Effective project management, organizational skills, and the ability to collaborate across departments are essential for success in this role.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Supply ManagementLogisticsInventory ManagementLabel DevelopmentBatch Release ManagementClinical Supply ProjectionsGxP ComplianceClinical Blinding PracticesBudget ManagementSOP Documentation
Soft Skills
Organizational SkillsProject ManagementResource ManagementTimeline ManagementCommunication Skills
Tools & Technologies
Microsoft ExcelIRT Systems
Industry Keywords
Pharmaceutical IndustryEU Clinical StudiesTemperature Excursion ManagementImport/Export LicensesCustoms FormsTrial Master File (TMF)Inspection Readiness
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