Clinical Project Manager

Highly Competitive Salary
  1. Permanent
  2. CRA Manager, Project/Study Manager (CSM/CPM)
  3. United States
North Chicago, USA
Posting date: 18 Feb 2021
CR.CN.35768

Proclinical is currently recruiting for a Clinical Project Manager with a biopharmaceutical company located in North Chicago, IL.

Job 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.
  • 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).

Skills and Requirements:

  • Bachelor's, Master's, or PharmD degree required preferably in scientific-related-field, math, engineering or pharmacy
  • Must have Project Management or Clinical experience
  • 2+ years of experience in the Pharmaceutical Industry in 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

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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