Clinical Project Manager

2 weeks ago


North Chicago, Illinois, United States Spectraforce Technologies Full time

Job Title:
Clinical Project Manager



Location:
1 N Waukegan Road AP9 North Chicago IL 60064
[The individuals are expected to work onsite Tuesday - Thursday each week. Mondays and Fridays have flexibility]

Duration: 12 Months


Summary:

  • Education Requirement: Bachelor's Degree required preferably in physical/biological science, math, engineering or pharmacy.
  • Experience: 2+ years total experience in the Pharmaceutical Industry.

Preferably experience in one of the following areas:

  • Drug discovery (eg, Process Chemistry, Analytical Chemistry)
  • Drug development (eg, Formulation)
  • Clinical operations (eg, Clinical Project Management)
  • Supply chain (eg, Clinical Supplies Project Management)
  • Quality Assurance
  • Major 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 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 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.


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