Study Start Up Specialist/Sr. Study Start Up Specialist

Added
17 hours ago
Type
Full time
Salary
Salary not provided

Related skills

gcp regulatory submissions contract negotiations tmf ich-gcp

📋 Description

  • Coordinate and oversee site activations per contract, protocol and regulatory requirements.
  • Lead study start-up activities and serve as main contact for Sponsor and internal teams.
  • Ensure regulatory deliverables developed, tracked, and aligned with procedures and templates.
  • Prepare and manage regulatory submissions and essential documents for TMF filing.
  • Coordinate with sites, CKTs and departments on document processing and site activation.
  • Support training, budgets, and proposal development as needed.

🎯 Requirements

  • Bachelor’s Degree in Chemistry or Life Sciences, Nursing or equivalent experience
  • Minimum 5 years in pharmaceutical/CRO industry
  • Experience managing multi-country start-up projects
  • Exceptional organization, planning, and problem-solving skills
  • Strong English written and verbal communication
  • Proficiency in MS Office (Word, Excel, PowerPoint)
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