Clinical Supply Manager

The Clinical Supply Manager is responsible for the end-to-end strategic planning and operational execution of clinical trial material (CTM) supply chains. This role leads the management of global Contract Development and Manufacturing Organizations (CDMOs) to ensure the timely packaging, labeling, and distribution of investigational products in compliance with global GxP regulations.

A key focus of this position is the oversight of Interactive Response Technology (IRT) systems, including system design, User Acceptance Testing (UAT), and real-time inventory management. The Manager acts as a central liaison between CMC, Clinical Operations, Quality Assurance, and Regulatory Affairs to align supply forecasts with patient enrollment and ensure trial master file (TMF) readiness. Additionally, the role provides financial oversight by managing project budgets, tracking vendor performance, and mitigating supply chain risks to maintain uninterrupted clinical study support.

Technical Management

1. Aggregate and quantify future requirements for clinical trial materials into a comprehensive supply/demand forecast at program and study levels, to develop CTM project plan and integrate the plan with clinical trial timeline by conducting capacity planning and inventory control to create supply and distribution plans.
2. Collaborate with Clinical Operations to align supply forecasts with real-time patient enrollment data.
3. Manage or supervise distribution/logistics activities of complex supply chains globally, by evaluating worldwide subject screening and enrollment progress, inventories at sites and depots, tracking expiry dates, initiating shipments, coordinating import/export requirements.
4. Proactively identify potential supply chain risks (e.g., shipping delays, production failures, or temperature excursions) and develop contingency plans to minimize impact on clinical timelines.
5. Prepare Requests for Proposals for activities in support of clinical supply projects.
6. Identify the most suitable CRO/CMO and initiate contracts. Oversee work assignment and deliverables for CTM suppliers and ensure timely completion of CTM milestones and internal development work. Manage and track CTM vendor contract, purchase orders, work orders, and invoices.
7. Provide technical support for vendor's IRT system in support of SK clinical studies.
   1. Monitor and manage real-time clinical supply inventories and site-level stock through Interactive Response Technology (IRT) from study start-up through closure.
   2. Analyze IRT reports to identify enrollment trends and proactively adjust site-level buffer limits to prevent stock-outs while minimizing waste.

• Participate in the execution of User Acceptance Testing (UAT) for IRT supply modules to verify system logic for randomization, kit assignment, and resupply triggers.

1. Assist to ensure accurate IRT data transfers for monthly reconciliation and maintain essential system documentation to ensure Trial Master File (TMF) and inspection readiness.

1. Consult on clinical study protocol, suitable CTM development and supportive stability plan, comparator sourcing, and clinical site selection. Lead cross-functional CTM supply team. Conduct CRA training for CTM supply.
2. Assist and support in writing and preparation of SOPs and interpreting and reviewing SOPs and study protocols.
3. 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.
4. Assist in the maintenance of SOPs related to reflecting current clinical supply activities. Assist and support Investigational Product Accountability, Returns, Reconciliation and Destruction at the end of the studies and collect all necessary documentation from vendors

1. Financial Management

1. Actively monitor the budget for individual study supply activities and materials for assigned projects. Maintain the cost trackers, invoices etc. Prepare and assist the FP&A team on project-specific spending and accrual monthly and quarterly basis, if requested.
2. Participate in project budgeting and forecasting process for the CMC Team's annual project budget management activities.

• Bachelor's degree in Pharmacy or related science and/or Supply Chain with 5-10 years of experience in the pharmaceutical industry with a focus in clinical supplies.
• Expert technical skills, good organization skills, ability to follow directions, and good communication skills.
• Proficiency with Microsoft Office, and in particular use of Excel and the ability to plot data.
• Understand protocols 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).
• Knowledge of warehousing, distribution (including cold chain distribution), and logistics.
• Ability to review, analyze, and interpret the IRT reports and specification requirements.
• Ability to understand, maintain, and demonstrate troubleshooting on vendor's IRT system.
• Ability to multitask.
• Adapts to change.
• Maintains composure under pressure.
• Ability to follow verbal and/or written instructions.
• Use of effective verbal communications
• Grasps information quickly
• Examines and observes details.
• Ability to work in a multi-cultural environment.