Clinical Supply Chain Analyst

Found in: Jooble UK C2 - 2 weeks ago

Ware Hertfordshire, United Kingdom Myn Full time
Job Purpose:The Supply Chain Study Lead (SCSL) role provides tactical oversight of the end-to-end supply chain for assigned GSK R&D clinical studies. The SCSL is accountable for defining detailed demand and supply plans for investigational medicines that consistently deliver those medicines on-time to patients while ensuring the supply chain delivers results that support published study milestones. This role is responsible for reviewing and influencing clinical protocols relative to investigational product (IP) supply and determining optimal supply plans that are patient-focused, risk-adjusted, and cost effective. Furthermore, the SCSL ensures timely execution of the plans and follows through on supply chain performance to ensure the successful delivery of the supply chain. This role supports Phase I through IV GSK sponsored clinical studies as well as investigator sponsored trials and compassionate use studies.Key Responsibilities:
  • Builds and maintains strong working relationships as the primary interface with the clinical study teams
  • Understands and challenges key assumptions and study planning parameters to ensure an optimal tradeoff across cost, risk, and benefit is achieved
  • Proactively engages with Clinical study teams to ensure supply options & risks are explored and agreed
  • Challenges planning information at the study level (e.g. patient enrollment forecast, etc.) and helps resolve logistical conflicts to ensure clinical supplies are off the critical path
  • Creates and maintains detailed, study specific demand and supply plans for assigned studies
  • Develops, implements, and maintains the IP supply plan for assigned studies
  • Accountable for ensuring that label content is defined and the data is set-up in the appropriate system(s) and liaising with relevant groups on pack design and pack component suitability
  • Works with business partners to oversee the effective execution of supply chain plans while proactively identifying potential obstacles to success and taking action to resolve issues
  • Supports externalization activities where vendors and/or partners are included in the supply chain
  • Create Study Specific Technical Agreements (or equivalent) for specified projects
  • Create inputs to vendor proposal request systems
Competencies:
  • B.S., M.S., Pharmacy, Chemistry or Logistics or equivalent experience in relevant field
  • Knowledgeable of clinical trial study designs and approaches and their implications for supply chain
  • Knowledgeable in the management of investigational product supplies and experience in inventory management
  • Demonstrated working knowledge of supply chain and planning principles
  • Ability to manage multiple and complex projects that require strong problem solving skills and creative or innovative thought to address global supply problems
  • Knowledgeable in regulatory requirements including Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCPs) and the Trial Master File
  • Demonstrated understanding of the drug development process
  • Knowledgeable and experienced in working with Interactive Response Technology (IRT) systems, especially with respect to supply management and patient randomization
  • Strong organizational and planning skills coupled with strong written and oral communication skills
  • Demonstrated capability to work with aggressive and changing timelines and with limited information and without defined absolutes
  • Knowledge of the technical challenges with regards to investigational product packaging and labeling
Preferred Requirements:
  • APICS or CILT certification
  • Lean Sigma training / experience
  • Project Management training / experience

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