Clinical Operations

  • location: North Chicago, IL
  • type: Contract
  • salary: $30 - $34.57 per hour
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job description

Clinical Operations

Job Title: Clinical Project Manager I (Non-MD)

Position 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.
Position Requirements

  • Bachelors Degree required preferably in physical 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)
  • 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).
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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