Fsp - Sr. Regulatory And Start Up Specialist

IQVIA

Buenos Aires, Argentina
Fully remote
Site activation activities
Regulatory and contractual documents
Local submissions
Perform start up and site activation activities according to applicable regulations, SOPs and work instructions

Job Summary

  • Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
  • Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
  • Provide local expertise to SAMs and project team during initial and on-going project timeline planning.

Matching Summary

Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.

Skills & Requirements

Must-have

  • Site Activation activities
  • Regulatory and contractual documents
  • Local submissions
  • Ethics committee presentations
  • ANMAT submissions

Nice-to-have

  • Single Point of Contact
  • Quality control of documents
  • Independent work ability
  • Project planning and timelines

Key Requirements

  • Bachelor's Degree in life sciences
  • +3 years clinical research experience
  • Regulatory area in Argentina
  • Fluent English

Work Rights

Not specified

Tailored Resume

Cover Letter