Local Study Startup Specialist

GSK

Canada
Base: cad91,000 to cad141,000; bonus/equity: not s...
**
Ich gcp compliance
Local regulatory compliance
Study site status tracking
** GSK is seeking a Local Study Startup Specialist to coordinate and manage the startup activities for clinical trials in Canada, ensuring compliance with regulatory standards and internal protocols. The ideal candidate will have experience in clinical operations and possess strong organizational skills to facilitate the timely activation of study sites. **

Job Summary

  • Leads the co-ordination and delivery of specialized operational activities according to ICH GCP, international and local regulations, and relevant GSK written standards.
  • Accountable to lead and collaborate with the Local Delivery Lead and Local Clinical Operations Specialists to ensure timely Start-up of all clinical trials across multiple therapeutic areas.
  • GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.

Matching Summary

Match Score: 75

** GSK is seeking a Local Study Startup Specialist to coordinate and manage the startup activities for clinical trials in Canada, ensuring compliance with regulatory standards and internal protocols. The ideal candidate will have experience in clinical operations and possess strong organizational skills to facilitate the timely activation of study sites. **

Salary

Base: CAD91,000 to CAD141,000; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • ICH GCP compliance
  • local regulatory compliance
  • study site status tracking
  • internal team communication
  • document preparation and filing
  • stakeholder collaboration

Nice-to-have

  • process simplification and optimization
  • keeping up with regulatory changes
  • learning from past activities
  • coaching and mentoring

Key Requirements

  • Experience with study site activation
  • Experience with ethics submissions
  • Experience with informed consent review

Work Rights

Not specified

Tailored Resume

Cover Letter