Manager/Senior Manager, Clinical Supply Chain Planning/Logistics Management
San Diego, CA, United States
Essential Job Functions
Responsible for developing drug supply inventory and overall logistics management of supplies for clinical studies
Coordinate drug supply delivery timelines with Clinical and CMC; Packaging, Labeling, and Distribution CRO’s
Monitor and track global clinical supply inventory at the clinical site level for studies; maintain forecasts, demand planning, and provide inventory and logistics management of IP adjusting drug distribution plans with coordination of packaging, labeling at Contract Packaging Vendors
Maintain close communications with all internal-chain groups to ensure the adequate supply of clinical supplies throughout the duration of multiple clinical trials
Serve as knowledgeable resource for managers throughout the organization on issues related to IP depot management, reconciliation, IVRS interface, and returns & destruction of un-used IP
Oversight of drug order requests and process and develop drug request forms to be utilized by sites when re-supplies are required
Support financial planning for global clinical supplies, including budgeting, forecasting, and strategic planning activities and reconciliation of drug distribution invoices with finance
Coordinate the origination, proofing and translation of clinical study labels, as required
Other duties as requested by supervisor
Job Requirements
Bachelor’s degree, RN, or equivalent, preferably in a scientific or pharmaceutical discipline
5+ years of prior experience in a pharmaceutical, biotech and clinical supply logistics environment preferred
Fundamental knowledge of inventory management and forecasting systemsand Clinical Trial supply processes
Working knowledge of Clinical Trials and the Clinical Trial Supply process
Proactively identifying potential issues, develop mitigating actions and notifying appropriate personnel in a timely manner
Hold a fundamental understanding of ICH guidelines, GCP’s, 21 CFR and Annex 13 requirements
General working knowledge of essential computer applications (i.e. MS Word, Excel, PowerPoint, MS Project) and working knowledge of IVRS systems
Ability to influence others
Ability to multi-task
Excellent verbal and written communication skills
The base range for a Manager is $135,000 - $154,000 and Senior Manager is $140,000- $150,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.
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