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Clinical Supply Chain Manager

Company: Beacon Hill Staffing Group - Pharma
Location: Lowell
Posted on: January 15, 2019

Job Description:

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%

Keywords: Beacon Hill Staffing Group - Pharma, Boston , Clinical Supply Chain Manager, Executive , Lowell, Massachusetts

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