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Senior Study Start-Up Specialist

7/5/2025

No location specified

Job Summary

A company is looking for a Senior Study Start-Up Specialist.

Key Responsibilities
  • Independently identify and resolve site-related issues impacting activation timelines
  • Manage preparation and submission of regulatory documentation and ensure compliance with local and international requirements
  • Collect and maintain regulatory and ethics approvals and ensure essential documents are submitted to the Trial Master File


Required Qualifications, Training, and Education
  • Bachelor's Degree or equivalent combination of education, training, and experience
  • Pharmaceutical or related industry experience, including regulatory and study start-up experience
  • Excellent knowledge of GCP, regulations, and Standard Operating Procedures
  • Ability to mentor and lead junior staff
  • Demonstrated ability to work independently and collaboratively in a fast-paced environment

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