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Title:
Clinical Project Manager I

Major Responsibilities:

  • Manage key Clinical Supply Chain activities at the protocol level for Phase I IV clinical trials.
  • Responsible for forecasting, planning, scheduling, coordination, and execution to ensure timely availability of investigational drug supplies and related services to clinical sites and depots.
  • Provide input to Clinical Study Teams to influence clinical protocol design for optimal supply chain resource utilization.
  • Translate clinical study design into packaging design and author the study medication and labeling sections of clinical protocols.
  • Develop protocol-specific labeling in compliance with applicable global regulations.
  • Identify, develop, communicate, and track project timelines, activities, logistics, and milestones.
  • Conduct protocol-specific clinical supplies scenario analysis, risk management, and contingency planning.
  • Forecast protocol-specific bulk drug product requirements, including comparator agents, ancillary supplies, and commodities, factoring in overages.

Education:

  • Bachelor's Degree required, preferably in physical/biological science, math, engineering, or pharmacy.

Experience:

  • Minimum of 2 years of experience in the Pharmaceutical Industry.
  • Preferred experience in one or more 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.

Critical Success Factors:

  • Strong understanding of clinical development and global supply chain requirements.
  • Competent in applying standard business requirements (e.g., SOPs, Global Regulations).
  • Knowledgeable about compliance in a regulated environment and able to apply this knowledge to daily tasks.
  • Effective collaboration within the department and cross-functionally, with a professional and tactful approach.

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ***.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Read the full job description and apply online on the recuiter's web-site

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