Clinical Project Manager Supply Chain

4 weeks ago

Lake County, United States Katalyst Healthcares & Life Sciences Full time
Responsibilities:
  • Responsible for the project management of key Clinical Supply Chain activities at the protocol level for and Phase I IV clinical trials.
  • Includes forecasting, planning, scheduling, coordination and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots.
  • Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources.
  • Translates clinical study design into packaging design. Authors the study medication and labelling section of the clinical protocol.
  • Develops protocol specific labelling compliant with applicable global regulations.
  • Identifies, develops, communicates and tracks project timelines, activities, logistics, and milestones.
  • Responsible for protocol specific clinical supplies scenario analysis, risk management and contingency planning.
  • Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies and commodities, including overages.
  • Critical Success Factors.
  • Understanding of clinical development and global supply chain requirements.
  • Competent in the application of standard business requirements (for example SOPs, Global Regulations).
  • Understanding the importance of compliance in a regulated environment and be capable of applying this knowledge to daily work.
  • Ability to work collaboratively within the dept as well as cross-functionally including interacting in a tactful, professional and effective manner.
  • Ability to work effectively and professionally with those in the dept as well as Clinical, QA, Analytical and any area interface.
  • Ability to manage and prioritize multiple tasks.
  • Project Management skills.
  • Good communication skills (both written and oral).
Requirements:
  • Bachelor's Degree required preferably in physical/biological science, math, engineering or pharmacy.
  • 2+ years total experience in the Pharmaceutical Industry.
  • Preferably experience in one of the following areas, Drug discovery (e.g., Process Chemistry, Analytical Chemistry).
  • Drug development (e.g., Formulation).
  • Clinical operations (e.g., Clinical Project Management).
  • Supply chain (e.g., Clinical Supplies Project Management).
  • Quality Assurance.

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