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Trial Supply Manager
Ref No.: 18-04214
Location: Malvern, Pennsylvania
Start Date / End Date: 04/23/2018 to 07/13/2018

The PDMS Clinical Supply Chain holds the global responsibility for all clinical supplies of the Client Research & Development portfolio and the Global Medical Affairs portfolio. Our activities include all in-house and outsourced manufacturing of clinical supplies (API, Drug Product, Packaged and Labeled Clinical Supplies), demand forecasting, supply planning, and global distribution of clinical supplies. Through a global network and organization (US, Switzerland, Belgium, Ireland, Netherlands, India), we are responsible for the manufacturing and scale-up of small and large molecules products in development and low volume commercial supply, and secure the supply to more than 60.000 patients in more than 330 clinical trials every year. We are actively seeking a Logistics Analyst, responsible for supporting global distribution activities for clinical supplies, to be based out of Malvern, PA or Titusville, NJ.

Description of Role:
This role is responsible for distribution plans and operational oversight of worldwide distribution activities of clinical supplies within Pharmaceutical Pharma R&D (large and small molecules; for all phases of clinical trials, primarily North and South America geographic regions with support to EU and ROW as required) as part of the Trial Supply Management organization.

Role Responsibilities:
• Monitor the performance of existing logistics and distribution providers and support efforts to ensure continuous improvement by the providers. Compile data and analyze trending through utilization of KPI and quality metrics.
• Manage and maintain the global knowledge database of best logistics practices, guidance, and requirements for the organization. Ensure that information is clear and valuable for use by Logistics end-users (Trial Design, Trial Supply Management, Global Clinical Organization).
• Analyze providers and vendors in collaboration with business partners (e.g. Procurement/Sourcing, Regional/Worldwide Transportation Organizations, QA) to identify new solutions and services, ensuring the most efficient and cost effective distribution providers are available to end users.
• Support and manage executional preparedness for the expanding reach of clinical trial operations. Analyze providers for capabilities and solutions to support these needs.
• Provide support to ensure the optimal logistics network is utilized during trial conduct.
• Support the development and implementation of solutions between IVR and Logistics provider network to ensure that order integrity is maintained and manual intervention is minimized in the order fulfillment process.
• Utilize resources to continuously analyze and recommend the optimal materials for cold-chain and other critical condition shipping materials. Manage the system to oversee global inventory management of these supplies.
• Leverage the RTO (Regional Transportation Organization) to apply existing compliance and security resources to the Trial Supply Management logistics network.
• Support/execute logistics projects as required
• Support Import/export issue resolution (primarily in the Americas with ROW support as required)
• Forecast for depots and couriers in order to make sure that they can commit to the distribution demand in order to deliver supplies on time and with the right quality.

• Bachelors degree and 3+ years in logistics / operations or similar industry + years related experience in logistics / operations or similar industry, or
• Knowledge and understanding of clinical study needs and clinical operations is preferred.
• Experience in managing distribution, transportation, and logistics.
• Knowledge of ambient, cold and / or frozen distribution requirements
• Knowledge of import/export processes
• Working knowledge of GCP/GMP processes is preferred
• Knowledge of IVRS functionality or EDI-based shipment order processing is a plus
• Ability to collaborate internally and externally to develop partnerships with key stakeholders and service providers to identify, shape, and deliver logistics and distribution solutions.
• Ability to work independently in a cross functional and cross cultural environment
• Strong operational and analytical skills
• Expertise in MS Excel for data trending and analysis
• Working knowledge of SAP and Logistics Track and Trace systems
• Understanding of 3rd party supplier purchasing (RFP), contractual, and budgeting processes

Travel: Up to 10%
Staff: 0
Language requirement: English