Study Start-Up (SSU) / CRA

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.