Mantell Associates is partnered with an innovative Life Sciences organisation, who is seeking a motivated hybrid Study Start-Up (SSU) / CRA professional for a part-time, contract role supporting study start-up activities for clinical trials in France and Italy. This is a fractional role focused on regulatory and site contracting tasks, with potential to expand into a larger opportunity.
Study Start-Up (SSU) / CRA - Responsibilities:
Regulatory Affairs:
* Main ICF Country Adaptation: Translate, review, and adapt the Informed Consent Form (ICF) to local requirements
* Pregnant Partner ICF Adaptation and Backtranslation
* Optional updates to ICFs as required to meet country-specific regulations
Site Contracting:
* Adapt contract templates to meet local institutional requirements
* Negotiate and finalize contracts with sites, ensuring smooth execution
Site Start-Up (SSU) / CRA - Requirements:
* Fluency in English and either French or Spanish (essential)
* Experience in ICF adaptation, backtranslation, and regulatory compliance
* Knowledge of site contracting and negotiations
* Strong organizational skills and ability to manage multiple tasks across France and Italy
* Comfortable working part-time/fractional in a hybrid capacity
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.