Study Start-up Lead

ICON

Multiple Locations
Study start-up and site activation management
Regulatory documentation preparation and tracking
Compliance with ich-gcp and local regulations
The Study Start-up/Site Activation Lead is responsible for managing start-up activities in compliance with client procedures, local and international guidelines such as ICH-GCP and relevant regulations

Job Summary

  • The Study Start-up/Site Activation Lead is responsible for managing start-up activities in compliance with client procedures, local and international guidelines such as ICH-GCP and relevant regulations.
  • ICON offers a diverse and inclusive culture that rewards high performance and nurtures talent, with competitive benefits focused on well-being and work-life balance.
  • The role involves close collaboration with CRAs and Local Study Teams to ensure timely achievement of study start-up milestones and regulatory compliance.

Matching Summary

The Study Start-up/Site Activation Lead is responsible for managing start-up activities in compliance with client procedures, local and international guidelines such as ICH-GCP and relevant regulations.

Skills & Requirements

Must-have

  • Study start-up and site activation management
  • Regulatory documentation preparation and tracking
  • Compliance with ICH-GCP and local regulations
  • Collaboration with CRAs and Local Study Teams
  • Use of CTMS and eTMF systems

Nice-to-have

  • Participation in Local Study Team meetings
  • Support for quality control checks
  • Providing regular updates to Line Managers
  • Fostering inclusive and diverse work culture

Key Requirements

  • Experience with clinical study start-up activities
  • Knowledge of ICH-GCP guidelines
  • Familiarity with regulatory submission processes
  • Ability to manage site regulatory documentation
  • Work authorization not specified

Work Rights

Not specified

Tailored Resume

Cover Letter