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Clinical Supply Operations Manager
2 months ago
Overview:
Position Summary:
Support the Associate Director in overseeing Contract Development and Research Organizations (CDMO) related to Clinical Supplies management.
Assist in the evaluation of packaging, labeling, storage, logistics, and distribution documentation for investigational products.
Contribute to the management of clinical supply inventories utilizing Interactive Response Technology.
Prepare data tables as necessary for data analysis.
Assist with documentation and manage internal and external change controls.
Support clinical supply activities for investigational products, including import/export processes, customs clearance, and handling of DEA Controlled Drugs.
Oversee the processing of CMC Team project invoices and internal budget requests (ARIBA), while monitoring project financials.
Assist the Quality Assurance Unit (QAU) in reviewing investigations and conducting vendor and internal audits.
Support Clinical Operations with document reviews related to study specifics, including pharmacy manuals, study protocols, and investigational brochures.
Key Responsibilities:
Technical Management
Collaborate with the team to prepare clinical supply request forms for new and ongoing studies as needed.
Draft requests for proposals to support clinical supply projects.
Review CDMO project proposals and provide feedback to the Associate Director prior to vendor selection, including reviewing and auditing slides, tables, and budget calculations.
Assist in preparing CDMO Vendor Comparison slides and support the selection of a suitable CDMO based on technical capabilities, cost-effectiveness, and timely delivery.
Utilize inventory forecasting software to ensure sufficient quantities of Clinical Trial Materials (CTMs) are available for clinical sites as required.
Assist in drafting and preparing regulatory submission documents, including drug product and drug substance sections in IND, annual reports, and informational amendments.
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.
Maintain SOPs to reflect current clinical supply activities.
Assist with Investigational Product Returns and Reconciliation at the conclusion of studies, collecting all necessary documentation from vendors.
Prepare Ariba processes for internal budget approvals for new and ongoing CMC Team projects.
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, as needed.
Participate in project budgeting and forecasting processes for the CMC Team's annual budget management activities.
Qualifications:
Bachelor's degree in chemistry (preferably analytical) with 5-8 years of experience in an analytical laboratory setting.
Ability to read, analyze, and interpret scientific protocols, reports, and technical journals, as well as financial reports.
Strong technical skills, excellent organizational abilities, and effective communication skills are essential.
Proficiency in computer applications, particularly Microsoft Office, with a strong emphasis on Excel and data plotting capabilities.
Understanding of protocols, ability to write SOPs, and technical knowledge of packaging and labeling processes.Familiarity with pharmaceutical stability protocols and expiration dating assessments for investigational drug products.
Knowledge of GMP batch record development, review, and approval processes.
Demonstrated understanding of the entire supply chain and its cost drivers.
Capability to execute the Clinical Supply portion of User Acceptance Testing (UAT) for the IRT system.
Knowledge of GCP and global cGMP regulations; familiarity with EU GMP QP regulations is a plus.
Understanding of warehousing, distribution (including cold chain logistics), and logistics is advantageous.
Ability to review, analyze, and interpret IVR/IRT reports and specification requirements is beneficial.
Proficiency in understanding, maintaining, and troubleshooting vendor's IRT/IVRS systems is an asset.