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Clinical Supply Chain Manager


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  • Beacon Hill Staffing Group - Pharma
  • 12/05/18
  • Boston, MA
  • 02108
  • Full-Time
Review clinical trial protocols and understand impact on supply
Partner with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, etc.
Create, review and update the clinical supply and demand plans based on strategic elements/study forecasts from Clinical Operations for studies and/or programs
Participate in cross-functional Project Team Meetings
Ensure changes in supply configuration, trial design, enrollment timelines, manufacturing availability and regulatory requirements are considered
Monitor inventory levels at depots and clinical sites through the life of a trial; take preventive actions to avoid potential supply issues
Manage label development process and packaging timelines
Coordinate US and international distribution and logistics with CMOs
Develop IRT and participate in User Acceptance Testing
Develop and maintain applicable metrics
Review and update SOPs and identify the need for an assist in establishing new departmental procedures
Qualifications
Bachelors degree in life sciences or business major
3+ years of pharmaceutical industry experience within clinical supply chain management (oncology and solid oral dosage form experience preferred).
Experience in CMO management, including labeling, packaging, and distribution in North America and Europe
Experience with IRT system and implementation
Knowledge of cGMPs and relevant FDA and EU Regulations
Familiarity with US and EU regulatory agencies and their guidance
Ability to communicate effectively both orally and in writing, both internally and with external vendors and partners
Ability to multi-task and work in a fast paced and dynamic environment
Strong working knowledge of standard business software, including MS Excel, Word, PowerPoint and Project
Strong analytical and organizational skills
Travel domestic and international possibly up to 10%


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