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Country Study Specialist

San Mateo Metro Area, CA

Posted: 07/11/2019 Job Type: Clinical Job Number: JN -072019-25216
Our biotechnology client is recruiting for a Country Study Specialist to join their growing team.

Overview:
  • Development and writing study documents including protocols, protocol amendments, CRFs, investigational brochures, annual report, and study guidelines
  • Work with global study team to manage or support the day-to-day activities of the study, including monitoring reports review, problem solving, issue escalation, timely closure of non-productive sites and tracking of safety procedures.
  • Management of various CROs and vendors involved in the study
  • Responsible for all start-up activities including but not limited to: site selection, drug preparation, enrollment, and data collection
  • Management of key study parameters and preparation of study updates
Requirements:
  • Bachelor s degree or equivalent undergraduate degree
  • 4-5 years in the pharmaceutical industry including in-house experience
  • Hands-on clinical trial experience including site monitoring
  • Solid experience developing/writing study documents
  • Ability to work as a team player and in a fast-paced environment
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