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Clinical Trial Oversight Manager

Thousand Oaks, CA
Description:
Remote - Any time zone

Ideal Candidate: B.S. and 5+ YOE. Previous experience in site monitoring - CRA site management. Strong GCP
  • Primary point of contact for FSP vendor(s) for resource and capacity management, portfolio planning and prioritization, performance management including the identification, escalation and resolution of quality and delivery issues
  • Provides support of clinical study execution
  • Provides GSO-SM functional area expertise and actively collaborates in a dynamic cross functional environment
  • Responsible for review and approval of FSP Quality Oversight Monthly reports
  • As requested, conduct in-person or remote Site Quality Visits to promote and maintain site quality and collaboration

Day to Day Responsibilities:    
  • Primary point of contact for FSP vendor(s) for resource and capacity management, portfolio planning and prioritization, performance management including the identification, escalation and resolution of quality and delivery issues.
  • Responsible for review and approval of FSP Quality Oversight Monthly reports.
  • As requested, conduct in-person or remote Site Quality Visits to promote and maintain site quality and collaboration.

Basic Qualifications    
  • Doctorate degree
  • Master’s degree and 2 years of experience
  • Bachelor’s degree and 4 years of experience
  • Associate’s degree and 8 years of experience
  • High school diploma / GED and 10 years of experience

Top 3 Must Have Skill Sets:    
  • Familiarity with advanced concepts of clinical research
  • Extensive knowledge of ICH/GCP regulations and guidelines
  • Strong knowledge of clinical trial operations
  • Understanding of Functional Service Provider operational model

Pay Rate  between $43 - $48/Hr on W2 based on experience.
 
"This posting is for Contingent Worker, not an FTE"

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