Clinical Supplies Manager

About the job Clinical Supplies Manager


Clinical Supplies Manager needs Bachelors degree in chemistry (preferred analytical) and up to 5-8 years of experience working in an analytical laboratory background


Clinical Supplies Manager requires:

CDMO management, Master Batch Records (MBR), Master Packaging Work Orders (MPWO), Interactive Response Technology (IRT), Interactive Web Response System (IWRS), Excel, Microsoft Office, ARIBA, Clinical Trial Material (CTM) inventory forecasting, regulatory submissions (IND, Annual reports, amendments), SOP writing, SOP review, study protocols, pharmaceutical stability protocols, GMP batch record development/review/approval, GCP, cGMP, supply chain management, budget management, financial tracking, RFP preparationve,

Bachelors 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 vendors IRT/IVRS system, a plus.

Clinical Supplies Manager duties

oAssist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies.

oReview master batch records (MBR), Master Packaging Work Orders (MPWO), and clinical related supplies-related documents.

oAssist and support the review of packaging, labeling, storage, logistics, and distribution documentation of the investigational product.

oAssist and support the management of clinical supply inventories using Interactive Response Technology.

oExpected to prepare data tables when needed for data interpretation.

oAssist with documentation and process internal and external change controls.

oAssist and support clinical supply activities for investigational products, such as import and export, customs clearance, DEA Controlled Drug experiences, etc.

oManage and processing of CMC Team project invoices and internal project budget requests (ARIBA), and monitoring of project financial tracking.

oAssist and support Regulatory Affairs (RA) to provide any documents for their submissions (US and Global).

oAssist and support the Quality Assurance Unit (QAU) regarding the review of investigations and conduct vendors and internal audits.

oAssist and support Clinical Operations on document reviews related to

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oAssist collaborated team to prepare clinical supplies request forms for new and existing studies when its need it.

oPrepare requests for proposals for activities in support of clinical supply projects.

oReview CDMO Project proposals and provide feedback to the Associate Director before selecting a specific vendor, review and audit slides, tables, and budget calculations.

oAssist 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.

oProvide technical support for vendors IRT/IWRS system in support of SK clinical studies.

oUtilize inventory forecasting software to ensure an adequate amount of CTMs is available to supply clinical sites when needed.

oAssist and support in writing and preparation of regulatory submission documents: drug product and drug substance sections in IND, Annual reports, and Informational amendments.

oAssist and support in writing and preparation of SOPs and interpreting and reviewing SOPs and study protocols.

oReview manufacturing, packaging, and labeling Master and Executed Packaging Work Orders/Batch Records (MBR/EBR, Packaging Labeling Approval Forms (PLAF), Labeling Approval Forms (LAF), etc.

oAssist and prepare Excel tables when needed.

oAssist in the maintenance of SOPs related to reflecting current clinical supply activities.

oAssist and support Investigational Product Returns and Reconciliation at the end of the studies and collect all necessary documentation from vendors.

oFinancial Management

oPrepare Ariba process for internal budget approval of new/ongoing CMC Team projects.

oPrepare, maintain, and monitor project budgets for the CMC Team

oReview and process clinical supply CMO invoices for project activities.

oPrepare and assist the FP&A team on project-specific spending and accrual monthly and quarterly basis, if requested.

oParticipate in project budgeting and forecasting process for the CMC Teams annual project


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