Job Details

  • Title: Clinical Project Manager
  • Code: RCI-06510
  • Location: North Chicago Illinois (IL) 60064
  • Posted Date: 10/09/2019
  • Duration: 12 Months
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  Job Description

Manager is not looking for PHD and MD level candidates


Clinical Project Manager

Education Requirement:

Bachelor’s Degree required preferably in physical science, math, engineering or pharmacy.

Experience Needed
  • 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 pre-clinical and Phase I – II 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
  • Project Management skills.
  • Ability to work effectively and professionally with those in the dept as well as Clinical, QA, Analytical and any area interface.
  • Understanding the importance of compliance in a regulated environment and be capable of applying this knowledge to daily work.
  • Understanding of clinical development and global supply chain requirements.
  • Competent in the application of standard business requirements (for example SOPs, Global Regulations).
  • Ability to work collaboratively within the dept as well as cross-functionally including interacting in a tactful, professional and effective manner.
  • Ability to manage and prioritize multiple tasks.
  • Good communication skills (both written and oral).