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Clinical Research Pharmacy Services Manager

Thousand Oaks, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and PuertRictbe vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”

Top 3 Must Have Skill Sets:        
  • licensed pharmacist, investigational drug /clinical trial supply management experience, hospital pharmacy experience
Day to Day Responsibilities:    
  • Provide input and support into the design of IP sections of study protocols
  • Provide input and feedback on drug packaging and labelling proposals for clinical studies
  • Assist in the development and implementation of preventive actions and process improvement initiatives related to
  • Investigational Product (IP) Management
  • Support internal stakeholders & networks to promote greater cross functional understanding and insight into
  • clinical IP needs, IP presentation and preparation challenges
  • Identify and support site challenges related to the clinical preparation, labeling, packaging and administration of IP
  • and bring these issues to the appropriate team(s) within this company for analysis and mitigation
  • Investigate potential IP risks identified at clinical sites and assist CRA/study teams with resolution and action
  • plans
  • Pro-actively explore dosing deviation trends and root causes to identify risk indicators and mitigation plans
  • Identify IP management training needs and develop support tools as required by this company and site personnel
  • Support development and regular review of Investigational Product Instruction Manual (IPIM) template, IPIMs and
  • associated documents
  • Act as the primary point of contact on behalf of this company for study related IP Management questions
  • Understand the capabilities of the clinical sites to inform internal testing of representative materials and delivery
  • approaches
  • Participate in Clinical Research Pharmacy Forum with other Big Pharma/Biotech companies
  • Collaborate with and support GDO stakeholders in responding to IP related audit/inspection queries
  • Provision of subject matter expert input and support into organization
Basic Qualification:
BS Pharmacy or PharmD
3-5 YOE

"This posting is for Contingent Worker, not an FTE"

 

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