Study Start-Up (SSU) / CRA

Mantell Associates; France; Hybrid; EUR 34,000 - 55,000; Part time

Job summary

A specialized headhunting firm in France is seeking a motivated hybrid Study Start-Up (SSU) / CRA professional for a part-time contract role. This position focuses on regulatory affairs and site contracting for clinical trials in France and Italy. The ideal candidate is fluent in English and either French or Spanish, with experience in ICF adaptation and strong organizational skills. This role offers flexibility with the potential to grow into a larger opportunity.

Qualifications

• Fluency in English and either French or Spanish is essential.
• Experience in ICF adaptation and regulatory compliance is required.
• Strong organizational skills are necessary for managing tasks across two countries.

Responsibilities

• Translate and adapt the Informed Consent Form for local regulatory requirements.
• Negotiate and finalize site contracts to ensure smooth execution of studies.
• Update ICFs to meet country regulations.
• Negotiate and finalize site contracts.

Skills

Fluency in English

Fluency in French or Spanish

ICF adaptation experience

Regulatory compliance knowledge

Site contracting negotiation skills

Organizational skills

Job description

Direct message the job poster from Mantell Associates

Overview

Mantell Associates is partnered with an innovative Life Sciences organisation, 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 fractional role focuses on regulatory and site contracting tasks, with potential to expand into a larger opportunity.

Responsibilities

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

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

Additional Information

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at [phone].

Job Attributes

• Seniority level: Mid-Senior level
• Employment type: Contract
• Job function: Science, Research, and Legal
• Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Chemical Manufacturing

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