Clinical Supplies Manager
Salary undisclosed
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About The Job
Summary of Position:
Summary of Position:
- 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, labelling, storage, logistics, and distribution documentation of the investigational product.
- Assist and support the management of clinical supply inventories using Interactive Response Technology.
- Expected to 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 processing of CMC Team project invoices and internal project budget requests (ARIBA), and monitoring of 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.
- Technical Management
- Assist collaborated team to prepare clinical supplies request forms for new and existing studies when its need it.
- Prepare requests for proposals for activities in support of clinical supply projects.
- Review CDMO Project proposals and provide feedback to the Associate Director before selecting a specific vendor, review and audit slides, tables, and budget calculations.
- Assist and prepare CDMO Vendor Comparison slides and assist in the selection of an appropriate CDMO based on technical ability, cost, and ability to deliver on time.
- Provide technical support for vendor's IRT/IWRS system in support of SK clinical studies.
- Utilize inventory forecasting software to ensure an adequate amount of CTMs is available to supply clinical sites when needed.
- Assist and support in writing and preparation of regulatory submission documents: drug product and drug substance sections in IND, Annual reports, and Informational amendments.
- Assist and support in writing and preparation of SOPs and interpreting and reviewing SOPs and study protocols.
- Review manufacturing, packaging, and labeling Master and Executed Packaging Work Orders/Batch Records (MBR/EBR, Packaging Labeling Approval Forms (PLAF), Labeling Approval Forms (LAF), etc.
- Assist and prepare Excel tables when needed.
- Assist in the maintenance of SOPs related to reflecting current clinical supply activities.
- Assist and support Investigational Product Returns and Reconciliation at the end of the studies and collect all necessary documentation from vendors.
- Financial Management
- Prepare Ariba process for internal budget approval of new/ongoing CMC Team projects.
- Prepare, maintain, and monitor project budgets for the CMC Team
- Review and process clinical supply CMO invoices for project activities.
- Prepare and assist the FP&A team on project-specific spending and accrual monthly and quarterly basis, if requested.
- Participate in project budgeting and forecasting process for the CMC Team's annual project budget management activities.
- 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.
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