Regulatory and Site Start Up Specialist

Added
less than a minute ago
Location
Type
Full time
Salary
Salary not provided

Related skills

regulatory affairs tmf ich-gcp site start-up irb/ec

📋 Description

  • Deliver timely site activation readiness for assigned country/sites and mitigate risks.
  • Prepare Clinical Trial Applications and submission dossiers on time.
  • Liaise with CA/EC for study submissions and responses.
  • Update Start Up Lead, Regulatory Lead, and Project Manager on submissions.
  • Maintain project plans, trackers, and regulatory tools for assigned duties.
  • Customize country/site specific Patient Information Sheet and ICF.

🎯 Requirements

  • Bachelor’s degree in life sciences or RN or equivalent.
  • Pharmacy/Pharmacist background would be highly beneficial.
  • 1+ year regulatory or site-start-up experience in CRO/pharma.
  • Strong communication and organizational skills.
  • Experience with computerized systems, spreadsheets, word processing, and email.
  • Fluency in English.
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