Clinical Supply Project Manager

Lake County, IL, US
Oct 31, 2018
Required Education
Bachelors Degree
Position Type
Full time
Key Responsibilities Include:
  • 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 IRT 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 overages.

  • Bachelor's Degree required, preferably in physical science, math, engineering or pharmacy.
  • 0 to 2+ years total experience in the Pharmaceutical industry.
  • Must have 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.
  • Proficient in the application of standard business requirements (for example SOPs, Global Regulations, OEC,).
  • Ability to work collaboratively across departments/functions and interact in a tactful, professional and effective manner.
  • Ability to manage and prioritize multiple tasks under tight deadlines and high pressure.
  • Strong Project Management skills.
  • Strong communication skills (both written and oral).

Equal Opportunity Employer Minorities/Women/Veterans/Disabled