Study Start-Up (SSU) / CRA

Mantell Associates; Paris; Sur place; EUR 35 000 - 55 000; Temps partiel

Résumé du poste

A specialist Life Sciences recruitment firm is seeking a motivated hybrid Study Start-Up (SSU) / CRA professional for a part-time, contract role in Paris. The role involves adapting regulatory and site contracting tasks for clinical trials in France and Italy. Candidates must be fluent in English and either French or Spanish, with experience in ICF adaptation and strong organizational skills. This opportunity offers flexible working arrangements.

Qualifications

• Experience in ICF adaptation and regulatory compliance.
• Knowledge of site contracting and negotiations.
• Ability to manage multiple tasks across France and Italy.

Responsabilités

• Translate and adapt Informed Consent Form (ICF) to local requirements.
• Negotiate and finalize contracts with sites.
• Adapt contract templates to meet local institutional requirements.

Connaissances

Fluency in English

Fluency in French or Spanish

Organizational skills

Description du poste

Overview

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.

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 [phone].