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Clinical Supplies Manager
2 months ago
We are seeking a highly skilled Clinical Supplies Manager to join our team at Unavailable. The successful candidate will be responsible for managing clinical supplies, including import and export, customs clearance, and DEA Controlled Drug experiences.
Key Responsibilities- Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies.
- Review master batch records (MBR), Master Packaging Work Orders (MPWO), and clinical related supplies-related documents.
- Assist and support the review of packaging, labeling, storage, logistics, and distribution documentation of the investigational product.
- Assist and support the management of clinical supply inventories using Interactive Response Technology.
- Prepare data tables when needed for data interpretation.
- Assist with documentation and process internal and external change controls.
- Assist and support clinical supply activities for investigational products, such as import and export, customs clearance, DEA Controlled Drug experiences, etc.
- Manage and process CMO invoices and internal project budget requests (ARIBA), and monitor project financial tracking.
- Assist and support Regulatory Affairs (RA) to provide any documents for their submissions (US and Global).
- Assist and support the Quality Assurance Unit (QAU) regarding the review of investigations and conduct vendors and internal audits.
- Assist and support Clinical Operations on document reviews related to the study specifics, such as pharmacy manual, study protocols, investigational brochures, etc.
- Bachelor's degree in chemistry (preferred analytical) and up to 5-8 years of experience working in an analytical laboratory background.
- Ability to read, analyze, and interpret basic scientific protocols, reports, and technical journals. Also, should be able to interpret financial reports.
- Expert technical skills, good organization skills, ability to follow directions, and good communication skills. Computer aptitude is a plus, especially proficiency with Microsoft Office, and in particular use of Excel and the ability to plot data.
- Understand protocols, write SOPs, and have technical knowledge of packaging and labeling activities.
- Knowledge of pharmaceutical stability protocols, assessment of expiration dating for investigational drug products.
- Knowledge of GMP batch record development, review, and approval process.
- Demonstrated understanding of the entire supply chain and associated cost drivers.
- Ability to execute the Clinical Supply portion of User Acceptance Testing (UAT) for the IRT system.
- Knowledge of GCP and global cGMP regulations, (knowledge of EU GMP QP regulations is preferred), a plus.
- Knowledge of warehousing, distribution (including cold chain distribution), and logistics, a plus.
- Ability to review, analyze, and interpret the IVR/IRT reports and specification requirements, a plus.
- Ability to understand, maintain, and demonstrate troubleshooting on vendor's IRT/IVRS system, a plus.
