Gwénaëlle Roguet
Senior Project Manager
Tours
Profil professionnel
Clinical Project Manager with 15+ years of experience in academic and CRO environments, managing interventional and non-interventional studies from start-up to close-out. Extensive experience across Phase I to Phase III international trials, including global studies across Europe and Africa. Strong expertise in project leadership, regulatory submissions, data management, and vendor oversight. Recently involved in preclinical and clinical start-up activities for vaccine and gene therapy programs, including COVID-19 development and early-phase studies.
Vue d'ensemble
18
18
years of professional experience
1
1
Certification
Expérience
Project Manager
ILIFE Consulting
2024.03 - 2026.04
- Lead planning, execution, and delivery of clinical studies in accordance with contracts and project plans
- Manage cross-functional and external teams (vendors, CROs, partners)
- Develop and oversee key study documents (Project Management Plan, Monitoring Plan, etc.)
- Contribute to protocol, ICF, CRF, and Clinical Study Report writing
- Prepare and support regulatory submissions and follow-up until approval
- Ensure studies are delivered on time, within budget, and to quality standards
- Identify and manage risks to ensure quality outcomes
- Oversee monitoring activities and subcontracted tasks
- Collaborate with Pharmacovigilance and Sponsor teams on safety oversight
- Contribute to Quality Management Systems and bid defense activities
Senior Clinical & Support Project Manager
Euraxi Pharma
2017.03 - 2024.03
- Managed full clinical trial lifecycle from concept to close-out
- Led multidisciplinary teams (DM, biostatistics, CRAs, regulatory, vendors)
- Oversaw international studies and vendor management (CROs, CDISC)
- Contributed to protocol, CRF, ICF writing and validation
- Supported regulatory submissions (CTIS, Ethics Committees, CNIL, international)
- Conducted feasibility and site selection (remote and on-site)
- Defined and implemented risk-based monitoring strategies
- Supervised CRA activities and ensured monitoring quality
- Managed study budgets and financial tracking
- Coordinated contracts (sites, vendors, investigators)
- Managed IMP supply and pharmaceutical logistics
- Developed risk management plans, PIA, and impact analyses
- Trained teams and mentored junior project managers
Clinical Trial Coordinator
AP-HP (Assistance Publique – Hôpitaux de Paris)
2008.07 - 2017.03
- Managed national and international clinical studies in vaccinology and infectious diseases
- Led protocol development, regulatory submissions (EC, ANSM, CNIL)
- Coordinated multidisciplinary teams and site activities
- Managed budgets and financial reporting
- Developed SOPs and study documentation
- Set up and managed clinical databases (eCRF)
- Drafted and managed contracts (CDA, MTA, hospital agreements)
- Organized international meetings (Steering Committees, DSMB)
- Contributed to scientific publications and presentations
Formation
Master’s Degree - Infectious Diseases, Immunology & Vaccinology
Bachelor’s Degree - Biology
Compétences
- Global Clinical Trial Management
- Early Phase Development
- Study Start-up
- Vendor/CRO Oversight
- Risk Management
- Quality Systems
- Cross-functional Team Leadership
- Elaboration and FU of key indicators/KPI
Certificats
- ICH-GCP (including R3 update)
- GDPR & Data Privacy
- Pharmacovigilance
- ISO 14155 (Medical Devices)
Informations complémentaires
Lecturer in Master’s programs (Vaccinology & Immunotherapy), Experience in international workshops and scientific communication, Former high-level athlete (competitive swimming – international level)
- Activités associatives
- Pratique du [Sport] depuis [Nombre] ans
Langues
French
Bilingue
English
Courant
Personnalisé
- EDC: Ennov, CleanWeb, ClinData, Clinsight, Inform, Viedoc, Fountayn
- CTMS: Ennov, internal systems
- ETMF: Veeva Vault
- IWRS/IVRS systems
- Microsoft Office Suite
- Literature databases: PubMed, Scopus
Chronologie
Project Manager - ILIFE Consulting
2024.03 - 2026.04
Senior Clinical & Support Project Manager - Euraxi Pharma
2017.03 - 2024.03
Clinical Trial Coordinator - AP-HP (Assistance Publique – Hôpitaux de Paris)
2008.07 - 2017.03
University of Tours - Master’s Degree, Infectious Diseases, Immunology & Vaccinology
University of Louisiana At Monroe - Bachelor’s Degree, Biology