Senior Regulatory & Start Up Specialist, Cfsp

IQVIA

Mexico City, Mexico
Site qualification and green light
Essential document collection and tracking
Ethics committee and regulatory authority submissions
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.
  • Oversee essential document collection, tracking & review and support the collection of country and site level intelligence.
  • 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

  • Site qualification and green light
  • Essential document collection and tracking
  • Ethics Committee and Regulatory Authority submissions
  • Country and site-specific activities
  • Fluent English communication skills
  • Veeva Vault proficiency

Nice-to-have

  • Goal oriented self-starter
  • Proactive issue identification
  • Detail oriented
  • Manage multiple tasks simultaneously

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter