ICF Specialist

Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
At least 2 years of ICF reviews, experience in reviewing all countries, but EU is a must.
EU/EEA knowledge, specifically experience reviewing ICFs before and after EU submissions.
Knowledge of CTIS. We don’t submit anything in CTIS ourselves but understanding how the submission process works and being able to check access system to review timelines RFI, etc. is helpful.
Reviewing ICFs for countries outside of Europe.
Any AI knowledge- we use-Copilot
In-depth knowledge of clinical systems, procedures, and corporate standards.
Good negotiating and communication skills with ability to challenge, if applicable.
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
Understanding of regulated clinical trial environment and knowledge of drug development process.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.