Local Study Startup Specialist

GlaxoSmithKline

Cad91,000 to cad141,000; not specified; not specif...
Hybrid
Ich gcp compliance
Local regulations adherence
Study site status tracking
GlaxoSmithKline is seeking a Local Study Startup Specialist to lead and coordinate the start-up activities for clinical trials, ensuring compliance with regulations and GSK standards. The role involves collaboration with clinical teams to maintain timelines and improve processes while supporting new team members

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 for maintaining internal tracking for study site status from initial site contact through site initiation.
  • 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: 85

GlaxoSmithKline is seeking a Local Study Startup Specialist to lead and coordinate the start-up activities for clinical trials, ensuring compliance with regulations and GSK standards. The role involves collaboration with clinical teams to maintain timelines and improve processes while supporting new team members.

Salary

CAD91,000 to CAD141,000; Not specified; Not specified

Skills & Requirements

Must-have

  • ICH GCP compliance
  • local regulations adherence
  • study site status tracking
  • internal team communication
  • documentation preparation and filing

Nice-to-have

  • process optimization
  • stakeholder collaboration
  • continuous improvement
  • coaching and mentoring

Key Requirements

  • Experience with study site activation timelines
  • Experience with ethics committee submissions
  • Experience with Informed Consent form review
  • Experience with document translation coordination

Work Rights

Not specified

Tailored Resume

Cover Letter