Study Start-Up (SSU) / CRA

Mantell Associates; Lyon; Sur place; EUR 40 000 - 60 000; Temps partiel

Résumé du poste

A leading consulting firm in Life Sciences is seeking a motivated hybrid Study Start-Up / CRA professional for a part-time contract role in Lyon. The position focuses on regulatory affairs, including ICF adaptation, and site contracting tasks. Fluency in English and either French or Spanish is essential, along with strong organizational skills. This fractional role supports clinical trials in France and Italy, providing a pathway to expand into a larger opportunity.

Qualifications

• Fluency in English and either French or Spanish is essential.
• Experience in ICF adaptation, backtranslation, and regulatory compliance is required.
• Strong organizational skills and ability to manage multiple tasks across France and Italy.

Responsabilités

• Translate, review, and adapt the Informed Consent Form (ICF) to local requirements.
• Negotiate and finalize contracts with sites, ensuring smooth execution.

Connaissances

Fluency in English

Fluency in French or Spanish

Experience in ICF adaptation

Knowledge of site contracting

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].