Senior Regulatory & Start Up Specialist, Cfsp

IQVIA UK

Mexico
End-to-end site management
Investigative site contact
Essential document collection
This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a point of contact for investigative sites and the study team members

Job Summary

  • This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a point of contact for investigative sites and the study team members.
  • Utilize systems and tools to track assigned activities and produce reports and metrics as needed.
  • Where required, complete, manage and/or support country and site-specific activities required to activate or maintain sites for a study as appropriate.

Matching Summary

This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a point of contact for investigative sites and the study team members.

Skills & Requirements

Must-have

  • End-to-end site management
  • Investigative site contact
  • Essential document collection
  • Ethics Committee submissions
  • Regulatory Authority submissions
  • Fluent English communication

Nice-to-have

  • Proactive issue identification
  • Goal-oriented self-starter
  • Detail-oriented approach
  • Interpersonal skills

Key Requirements

  • Bachelor’s Degree or equivalent experience
  • Minimum of three years relevant experience
  • Experience in EC submission in Mexico
  • ICF customization experience
  • Proficiency with Veeva Vault
  • Ability to negotiate complex contracts

Work Rights

Not specified

Tailored Resume

Cover Letter