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The Manager, Clinical Supply Management is responsible for forecasting Investigational Product (IP) supply requirements for multiple clinical trials and for managing the IP distribution process to one or more clinical trials. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and Nektar's SOPs. Contributes to ongoing process improvement initiatives. This role applies to internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, therapeutic area project managers, medical monitors, as well as staff from quality, clinical compliance, regulatory, formulations, CMC, external manufacturing, and stability. Effectively meets the customer expectations in the delivery of CSM to support the key Nektar Clinical milestones for study starts and patient resupply.
Supply Planning: Serves as lead logistics manager for the functional area in supply planning, including demand forecasting. Manages supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan; Works with CSM management to determine resourcing needs; Provides input to the development of IP-related study documents including protocols, study and pharmacy manuals; Responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution and return/destruction, and/or helping to establish these timelines; Oversees setup and management of IVRS (IWRS)
Manages and tracks investigational product (IP) inventory; advises supply management team of potential shortages and makes recommendations for resupply activities based on usage trends by performing routine forecasting / demand planning. Oversees IP shipment orders according to supply plans to ensure timely and compliant shipment and delivery to investigator sites from order request thru acknowledgement of receipt by the clinical site. IVRS: Working knowledge and experience with Interactive Response Technologies (IRT); Work with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rd party vendors. Lead effort for clinical supply management functionality; Monitor and manage clinical supply activities through IRT from study start-up through study closure; Ensure appropriate system documentation is transferred to Nektar for TMF and inspection readiness.
Reviews and evaluates temperature excursion data by following relevant SOP; provides assessments to supply management team regarding excursion trends in each study. Reviews drug return and destruction records; communicates with investigator sites, CROs and external vendors to resolve issues. Performs 100% drug accountability from bulk drug, production, distribution, and returns / destruction. Monitors IP expiry data and informs CSM and CMC teams of pending IP expiry needs. Develop plans for supplying clinical study sites with ancillary supplies, either through in-house initiated supply or working with supply vendors. Ensures appropriate documentation of IP supply activities is provided for the Trial Master File. Reviews IVRS specs and reviews IVRS user manuals; Designs, reviews and approves IP-related labels and study tools (for clinical study teams and investigative site use), as needed. Supports inspection team in preparation for and during regulatory agency inspection. Represents CSM on cross-functional study team (s) and/or sub-team(s); Effectively communicates with CROs, shipping and IVRS vendors, study sites and study team members to ensure ongoing successful execution; Acts as point of escalation for IP-related issues. Leads management of IP service vendors (performance, quality, timelines, deliverables, costs); Participates in preparation of RFP, assumptions and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS); Provides input, reviews, and approves vendor study specifications; Serves as point of escalation for vendor-related IP issues as they arise; Reviews and approves/scrutinizes specified costs on vendor invoices against contract, as delegated; Recommends vendors to CSM and Clinical Study Teams.
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