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Sr Business Analyst

3 months ago

WinstonSalem, North Carolina, United States Inteldot Full time

Sr. Business Analyst/Pharmaceutical Clinical Supply Chain with business process and technology expertise:

Individual will support a new initiative to manage clinical supply chain and patient journey:

Responsibilities:

  • Support refinement of business requirements specification to meet company needs
  • Articulate, review and elaborate use cases and corresponding business requirements in partnership with supply chain, manufacturing, clinical and quality.
  • Manage configuration of system according to use cases and business requirements.
  • Partner with vendor and internal stakeholders to update and refine project documentation
  • Coordinate review and approval of project and validation deliverables across stakeholders
  • Test drive use cases and system configurations to ensure it meet business needs
  • Highlight configuration issues with vendor and ensure to keep track of reported issues and fixes
  • Work with offshore testers refine test scripts
  • Provide support for development of business process documentation, SOPs, and WIs as needed.
  • Track overall milestones, issues, and risks related to delivery of project
  • Support development of project plans in accordance with business practices and integrating internal and vendor activities
  • Support development of training plan for rollout of business system capability across global clinical sites
  • Support development of support model for technology, process, and data
  • Support development of business process diagrams based on system functionality

Experience:

  • Must have Understanding of Pharmaceutical Supply Chain
  • Must have understanding of systems and technologies to support pharmaceutical supply chain
  • Must have understanding of clinical trials, site start-up, and clinical supply chain processes
  • Prefer having experience with deployment global capabilities in support of supply chain, clinical, and commercialization of cell and gene therapy
  • Have a good understanding of project management including agile methodologies
  • Have a good understanding of business analysis methodologies
  • Background with deploying capabilities across FDA regulated industry and background must include validation
  • Background with cell therapy supply chain is a plus
  • Experience with Trakcel, CellChain or Vineti Supply Chain Software is a must