Clinical Trial Application Submission Manager (cta-sm)

ICON Clinical Research, LP

Not specified; not specified; competitive salary m...
In-depth understanding of cta processes
Proven execution of central ethics processes
Ability to manage global submission strategies
ICON is a world-leading healthcare intelligence and clinical research organization seeking a Manager to drive global submission management strategy

Job Summary

  • ICON is a world-leading healthcare intelligence and clinical research organization seeking a Manager to drive global submission management strategy.
  • The role involves partnering with study teams to manage regulatory activities, ensuring high-quality components compliant with industry guidelines.
  • ICON offers competitive benefits including health insurance, retirement planning, and a global Employee Assistance Programme focused on well-being.

Matching Summary

ICON is a world-leading healthcare intelligence and clinical research organization seeking a Manager to drive global submission management strategy.

Salary

Not specified; Not specified; Competitive salary mentioned

Skills & Requirements

Must-have

  • In-depth understanding of CTA processes
  • Proven execution of Central Ethics processes
  • Ability to manage global submission strategies
  • Experience with HA/Regional CTA Hub submissions
  • Coordination of translations for core documents

Nice-to-have

  • Quickly learn new software and regulations
  • Strong technical aptitude for quality standards
  • Experience with IVD submission development
  • Proactive processing of incoming RFIs
  • Effective communication with study teams

Key Requirements

  • B.S./B.Sc in Pharmacy, Life Sciences, Business, or IT
  • Equivalent relevant professional experience considered
  • Technical aptitude to use new software and regulations

Work Rights

Not specified

Tailored Resume

Cover Letter