Clinical Supply Chain Lead
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Clinical Supply Chain Lead
Ref No.: 18-01021
Location: Waltham, Massachusetts
Position Type:Contract
Shift:First
Job Category:Biotech/Pharmaceutical
Benefits:401K, Dental Insurance, Life Insurance, Medical Insurance, None, Vision Insurance
*Please note that this is a 4 month contract assignment. Candidates cannot start an assignment until background check and drug test is completed*

The Clinical Supply Chain Lead will be responsible for ensuring continuous product supply for drug products in support of clinical trials.

 The individual will work with internal and external customers and suppliers in order to accomplish project objectives. The individual will develop early stage DS, DP and IMP packaging and distribution plans. Responsible for monitoring inventory levels and providing feedback to the appropriate resources regarding expiry and resupply. In addition, the individual will support Clinical Supply Chain initiatives and continuous improvement activities.

Job responsibilities:
• Drive/lead end-to-end clinical supply chain activities to ensure successful trial supply management
• Partner with Clinical Operations to identify demand assumptions and create, review and update the clinical supply and demand plans based on strategic elements/study forecasts from Clinical Operations for studies and programs
• Review clinical trial protocols and understand impact to supply
• 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 preventative actions to avoid potential supply issues
• Support development of IRT and participate in User Acceptance Testing
• Develop and maintain applicable metrics
• Review and update SOPs and identify the need to assist in establishing new procedures
• 3-5 years of pharmaceutical industry experience within clinical supply chain management
• Experience in CMO management, including labeling, packaging, and global distribution
• Experience with IRT and ERP (Oracle, SAP, etc.) systems
• 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

Education: Bachelor’s degree in Engineering, Life Sciences or Business

To apply for this position please send resumes to katie.lee@onboardusa.com and reference job #18-01021