Clinical Project Manager II

2 weeks ago

North Chicago, Illinois, United States The Fountain Group Full time
Pay: $70-75/hr
Location: Hybrid in North Chicago, IL; The individuals are expected to work onsite Tuesday - Thursday each week. Mondays and Fridays have flexibility
Duration: 1 year initially

MANAGER NOTES:
Day to Day:
  • Interpret protocol from clinical suppliers, interface with study team members to understand what counties the study will participate in with number of sites,
  • Create a clinical supply forecast of how much drug product is needed - FORECASTING IS KEY
  • Ensure right drug delivered to right patient at the right time
  • Work with interactive response technology (IRT) - ensure study parameters work within the IRT
Additional Notes:
  • The manager is looking for experienced clinical supply chain project management experience.
  • Must have at least 3 years of experience related to clinical supply chain
  • 10+ years of experience is not overqualified
  • Global clinical supply chain experience highly preferred (know what countries require import licenses)
  • Key words: forecasting, IRT, Supply Chain
  • Must have an intermediate knowledge of Excel
  • Smartsheets preferred
  • Education Requirement: Bachelor's Degree required preferably in physical/biological science, math, engineering or pharmacy.
  • Must have 3+ years clinical supplies project management experience in the Pharmaceutical Industry.
Major Responsibilities:
  • Responsible for the project management of key Clinical Supply Chain activities at the protocol level for Phase 1, 2, 3, 4 and IIS studies of increasing complexity
  • 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 labeling section of the clinical protocol.
  • Develops protocol specific labeling compliant with applicable global regulations.
  • Identifies, develops, communicates and tracks project timelines, activities, logistics, and milestones.
  • Responsible for creating appropriate protocol specific manufacturing and packaging work orders in concert with Third Party and IVRS vendors, QA, clinical team partners etc to ensure timely availability of clinical supplies.
  • 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 overage
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).

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