Clinical Supply Chain Planner

The Clinical Supply Chain Planner is responsible for the management and oversight of end to end clinical supply chain activity for assigned clinical protocols. This position works closely with key stake holders including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs, Contract Manufacturing Operations (CMO’s), and Contract Research Operations (CRO’s) to ensure seamless supply of Clinical Trial Material. 

Some key areas of management/oversight include forecasting, packaging, labeling, distribution, inventory management, financial planning/ budgeting, vendor oversight, and eTMF filing of Clinical Supply documents. A successful candidate will be skilled at understanding the Clinical Supply needs and responsibilities, exhibit strong attention to detail, support a collaborative environment with a strong communication skillset, and the ability to prioritize workload and meet project timelines.

Summary of Key Responsibilities:

·      Managing packaging, labeling, and distribution of clinical trial material for global clinical trials

·      Support (Interactive Response Technology) IRT development, user acceptance testing (UAT), and system oversight, as well as utilize the system to actively manage clinical trial material.

·      Utilize and support the management and use of home-grown budget forecasting and planning tool

·      Partner with Clinical Operations to align on demand assumptions

·      Develop supply strategies to maximize supply efficiency and minimize waste

·      Design and actively manage supply & demand forecasts in our web-based optimization tool

·      Identify potential supply risks, and develop risk mitigation plans as necessary

·      Drive label creation and approval process, including translations and regulatory requirements

·      Communicate clinical supply requirements to Global Planning and ensure seamless coordination of demand and supply

·      Support return and destruction of clinical trial material for assigned protocols

·      Manage program and/or protocol budget, monitor Key Performance Indicators (KPIs), and strive to achieve relevant cost saving targets

·      Maintain collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirements

Qualifications

·      BS degree in Life Sciences or Supply Chain Management

·      Experience: Minimum 3+ years of experience in clinical supply

·      Understanding of end to end clinical supply chain activity

·      Experience with supply/demand forecasting systems a plus (eg. NSIDE, Bioclinica, 4G, Oracle, etc)

·      Experience with IRT systems

·      Strong understanding of GxP

·      Proficient knowledge of MS Office (Excel, PowerPoint, Visio, Project, etc)

·      Demonstrated flexibility to adapt to external environment influences through identifying new strategies and tactics

·      Strong attention to detail

·      Excellent communication, collaboration, and influencing skills

·      Ability to multi-task and manage complex challenges