Clinical Supplies Manager
About The Position
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. This role involves assisting and supporting the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies. The position requires reviewing various documents such as master batch records, Master Packaging Work Orders, and clinical supplies-related documents. Key responsibilities include supporting the review of packaging, labeling, storage, logistics, and distribution documentation of investigational products, managing clinical supply inventories using Interactive Response Technology, and preparing data tables for interpretation. The role also involves assisting with documentation and process internal and external change controls, supporting clinical supply activities like import/export, customs clearance, and DEA Controlled Drug experiences. Financial management includes managing and processing Contract Manufacturing Organization (CMO) project invoices and internal project budget requests, and monitoring project financial tracking. Additionally, the role supports Regulatory Affairs (RA) by providing documents for submissions and assists the Quality Assurance Unit (QAU) with investigations and vendor/internal audits. Support is also provided to Clinical Operations for document reviews related to study specifics.
Requirements
- 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.
- Ability 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.
Nice To Haves
- 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.
Responsibilities
- Assist collaborated team to prepare clinical supplies request forms for new and existing studies.
- 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 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.
- 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.
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What This Job Offers
Career Level
Mid Level
