Clinical Supplies Manager

Location: Paramus, NJ, 07652
Duration: 3 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: 9:00 AM – 5:00 PM

About the Role

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 documentation. Support the review of packaging, labeling, storage, logistics, and distribution documentation of investigational products. Manage clinical supply inventories using Interactive Response Technology and prepare data tables for data interpretation. Assist with documentation and process internal and external change controls, as well as clinical supply activities for investigational products, including import/export, customs clearance, and DEA Controlled Drug experiences. Manage and process CMC Team project invoices and internal project budget requests (ARIBA), and monitor project financial tracking. Support Regulatory Affairs (RA) in providing documents for submissions (US and Global) and assist the Quality Assurance Unit (QAU) with investigations, vendor audits, and internal audits. Support Clinical Operations on document reviews related to study specifics, such as pharmacy manuals, study protocols, and investigational brochures.

Responsibilities

• Assist in preparing clinical supplies request forms for new and existing studies.
• Prepare requests for proposals for activities supporting clinical supply projects.
• Review CDMO project proposals and provide feedback to the Associate Director, including reviewing slides, tables, and budget calculations.
• Assist in preparing CDMO Vendor Comparison slides and support vendor selection based on technical ability, cost, and delivery timelines.
• Provide technical support for vendors’ IRT/IWRS systems in support of clinical studies.
• Utilize inventory forecasting software to ensure adequate clinical trial materials (CTMs) are available for clinical sites.
• Assist in writing and preparing regulatory submission documents, including drug product and drug substance sections in INDs, Annual Reports, and Informational Amendments.
• Support the writing and preparation of SOPs and interpret/review SOPs and study protocols.
• Review manufacturing, packaging, and labeling documentation, including Master and Executed Batch Records (MBR/EBR), Packaging Labeling Approval Forms (PLAF), and Labeling Approval Forms (LAF).
• Prepare Excel tables as needed.
• Maintain SOPs to reflect current clinical supply activities.
• Assist with Investigational Product Returns and Reconciliation at the end of studies, collecting necessary documentation from vendors.
• Prepare Ariba processes 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.
• Assist the FP&A team with project-specific spending and accruals on a monthly and quarterly basis.
• Participate in project budgeting and forecasting for the CMC Team’s annual project budget management.

Qualifications

• Bachelor’s degree in chemistry (preferred analytical) with 5-8 years of experience in an analytical laboratory background.
• Ability to read, analyze, and interpret scientific protocols, reports, technical journals, and financial reports.
• Expert technical skills, strong organizational abilities, and proficiency in following directions and communication.
• Computer proficiency, particularly with Microsoft Office (Excel for data plotting).
• Understanding of protocols, SOP writing, and technical knowledge of packaging and labeling activities.
• Knowledge of pharmaceutical stability protocols and assessment of expiration dating for investigational drug products.
• Knowledge of GMP batch record development, review, and approval processes.
• Demonstrated understanding of the supply chain and associated cost drivers.
• Ability to execute the Clinical Supply portion of User Acceptance Testing (UAT) for IRT systems.
• Knowledge of GCP and global cGMP regulations (EU GMP QP regulations preferred).
• Knowledge of warehousing, distribution (including cold chain), and logistics (preferred).
• Ability to review, analyze, and interpret IVR/IRT reports and specification requirements (preferred).
• Ability to troubleshoot vendor IRT/IVRS systems (preferred).