Specialist Study Start Up & Regulatory Affairs

Added
7 days ago
Type
Full time
Salary
Salary not provided

Related skills

documentation regulatory affairs tmf regulatory compliance study start-up
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๐Ÿ“‹ Description

  • Under guidance of senior team members, independently manages study start-up activities for projects
  • Prepare, collect, review regulatory information to support submissions to national authorities and
  • Collect, review for completeness and compliance, and track essential documents for Study Start-Up
  • Responsible for drafting, negotiating, finalizing, and executing clinical site agreements
  • Responsible for site outreach in assigned country/countries; point of contact for site, sharing of
  • Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other

 

 

 

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