Fsp Country Approval Specialist

Thermo Fisher Scientific UK

Unknown, United Kingdom
Not specified (likely office-based due to "office job description").
Clinical trial site start-up experience
Review of essential documents icf fdf 1572 cvs
Knowledge of fda and ich-gcp guidelines
Thermo Fisher Scientific is seeking a Country Approval Specialist to facilitate site startup and enhance communication within clinical research teams. The ideal candidate will have experience in clinical research, particularly in site startup processes, and will be responsible for ensuring compliance with industry standards

Job Summary

  • The role supports the facilitation of site start-up and ensures prompt site approval to meet study timelines.
  • Candidates must review site essential documents including ICF, FDF, 1572, and CVs while ensuring accuracy in the eTMF.
  • The position requires a deep understanding of pharmaceutical industry processes, clinical trial agreements, and fair market value principles.

Matching Summary

Match Score: 85

Thermo Fisher Scientific is seeking a Country Approval Specialist to facilitate site startup and enhance communication within clinical research teams. The ideal candidate will have experience in clinical research, particularly in site startup processes, and will be responsible for ensuring compliance with industry standards.

Skills & Requirements

Must-have

  • Clinical trial site start-up experience
  • Review of essential documents ICF FDF 1572 CVs
  • Knowledge of FDA and ICH-GCP guidelines
  • Understanding of clinical study protocols
  • Experience with Contract and Budgeting principles

Nice-to-have

  • Strong organizational and decision-making skills
  • Ability to explain data for decision making
  • Excellent communication and negotiation skills
  • Proven ability to work across cultures
  • Data-driven approach to problem solving

Key Requirements

  • Bachelor's degree or equivalent
  • 2+ years of clinical research site start-up experience
  • Activation experience required
  • Proficiency in Microsoft Excel, Word, and PowerPoint

Work Rights

Not specified

Tailored Resume

Cover Letter