Description

J'ai 18 ans d'expérience dans l'industrie de la recherche clinique et les Affaires Réglementaires. J'ai évolué en tant que SSU Associate (Spécialiste Start-Up / Activation de sites) durant la majeure partie de mon parcours (incluant un double rôle de Site Activation Leader). Lors de mon dernier poste, j'ai été promue Manager d'une équipe SSU composée de 20 collaborateurs répartis en Europe, aux États-Unis, au Canada, au Mexique et en Argentine. J'ai appris sur le terrain ainsi qu'à travers les formations internes des entreprises.

Les compétences clés que j'ai acquises sont les suivantes :

Soumissions de protocoles auprès des Comités d'Éthique et des Autorités de Santé.

Coordination des activités de soumission menées par des experts locaux à l'échelle internationale.

Gestion de projets (en phase de Start-Up / lancement) et allocation des ressources, avec un accent mis sur la qualité, l'efficacité et la maîtrise des coûts.

Recrutement et formation de nouveaux membres d'équipe à travers le monde.

Contribution à la création, au développement et à la mise en œuvre des processus internes de l'entreprise.

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