Global Studies Associate

ICON plc

Not specified; competitive salary offered; range o...
**
Manage electronic trial master file (etmf)
Ensure ich/gcp compliance
Experience with ctms systems
** ICON plc is seeking a Global Studies Associate to support clinical research initiatives by managing electronic Trial Master Files, collaborating with study teams, and ensuring compliance with regulatory guidelines. The ideal candidate should possess a background in medical or biological sciences, along with experience in eTMF and CTMS systems. **

Job Summary

  • ICON is a world-leading healthcare intelligence and clinical research organization fostering an inclusive environment.
  • The role involves initiating and maintaining the electronic Trial Master File (eTMF) to ensure compliance with ICH/GCP guidelines.
  • Candidates will collaborate with global teams to coordinate study materials, administrative tasks, and regulatory inspections.

Matching Summary

Match Score: 75

** ICON plc is seeking a Global Studies Associate to support clinical research initiatives by managing electronic Trial Master Files, collaborating with study teams, and ensuring compliance with regulatory guidelines. The ideal candidate should possess a background in medical or biological sciences, along with experience in eTMF and CTMS systems. **

Salary

Not specified; Competitive salary offered; Range of additional benefits including health insurance and retirement planning

Skills & Requirements

Must-have

  • Manage electronic Trial Master File (eTMF)
  • Ensure ICH/GCP compliance
  • Experience with CTMS systems
  • Coordinate clinical study documents
  • Support regulatory submissions

Nice-to-have

  • Veeva Vault experience preferred
  • Global study support experience
  • Medical or biological sciences education
  • Ability to train others on procedures
  • Strong organizational and analytical skills

Key Requirements

  • Education in medical or biological sciences preferred
  • Proven administrative training/experience
  • Computer proficiency required
  • Working knowledge of Clinical Study Process
  • Excellent verbal and written communication in English

Work Rights

Not specified

Tailored Resume

Cover Letter