Freelancer profile translated to English.

Description

I have 18 years of experience in the clinical research industry and Regulatory Affairs. I evolved as an SSU Associate (Start-Up / Site Activation Specialist) for most of my career (including a dual role as Site Activation Leader). In my last position, I was promoted to Manager of an SSU team composed of 20 collaborators spread across Europe, the United States, Canada, Mexico, and Argentina. I learned on the field as well as through internal company training.

The key skills I have acquired are:

Protocol submissions to Ethics Committees and Health Authorities.

Coordination of submission activities carried out by local experts on an international scale.

Project management (in the Start-Up / launch phase) and resource allocation, with a focus on quality, efficiency, and cost control.

Recruitment and training of new team members worldwide.

Contribution to the creation, development, and implementation of the company's internal processes.

Languages

French
Native or bilingual
English
Native or bilingual

Workplace preferences

Can work on-site

Boulogne-Billancourt (up to 50km)

ICON Plc
Start-up Team Manager
November 2021 - November 2023 (2 years)
Boulogne-Billancourt, France
• Line Management of 15-20 Study Start-Up Associates (SSUAs) in Europe and the Americas
• Recruitment, onboarding, training and performance management of SSUA team members
• Oversight of global Study Start-Up activities and allocation of resources based on study priorities
• Ensure timely and compliant delivery of country and site-level submissions in accordance with ICH-GCP and local regulations
• Drive quality, efficiency and cost optimization throughout the Start-Up phase
• Contribution to the development and implementation of internal processes and best practices
Soumissions Réglementaires CTIS
ICON Plc
Senior Study Start-Up Associate and Site Activation Lead
April 2015 - October 2021 (6 years and 6 months)
• Proposal to sponsors of adapted strategies for Ethics Committee/Institutional Review Board and Competent Authority submissions in Europe, United States of America, Canada, Mexico, Peru, Australia and New Zealand
• Presentation in Boston of submission strategy during a kick-off meeting with the sponsor
• Cross-functional collaboration with sponsors and country SSUAs to ensure timely submissions and approvals
• Mentoring, training and day-to-day support of junior Study Start-Up team members
• Back-up management of the France Study Start-Up team, including workload and resource planning
• Preparation, review and submission of regulatory packages for France and Belgium to obtain clinical trial authorizations and approvals
• Management of regulatory maintenance activities, including amendments and safety updates
• Adaptation of country specific SIS/ ICFs as per French and Belgian regulations
• Preparation of essential documentation for site activation
ICON Plc
Study Start-Up Associate - Level I and II
September 2007 - March 2015 (7 years and 6 months)
• Preparation, review and submission of regulatory packages for France and Belgium to obtain clinical trial authorizations and approvals
• Management of regulatory maintenance activities, including amendments and safety updates
• Adaptation of country specific SIS/ ICFs as per French and Belgian regulations
• Preparation of essential documentation for site activation
• As required - review and translate drug labels