MARION SAGARDOYTHO
Paris,France
Summary
Senior Clinical Research Associate with extensive international experience (France, UK, Australia). Expertise in oncology (Phases I–III) and vaccines, from selection to closure, regulatory compliance, Good Clinical Practice (GCP), RECIST 1.0, TMF/eTMF, clinical team coordination, and budget management. Rigorous and quality-oriented approach with a strong sense of priorities.
Overview
17
17
years of professional experience
1
1
Certification
Work history
Senior Clinical Research Associate
TigerMed CRO
Sydney, Australia
2022.05 - 2025.11
Oncology Phases I–II
• Full site oversight (selection to close-out)
• On-site and remote monitoring
• SDV / SDR - RECIST 1.0
• Pharmacy and IP stock management
• Biological sample shipment tracking
• Ethics submissions
• PV and CAPA management
• TMF / eTMF
Clinical Research Associate
PPD
Sydney, Australia
2020.08 - 2021.10
COVID-19 studies (Novavax Vaccine Phase III)
• Site feasibility and selection
• EDC monitoring (SDV / SDR)
• eTMF
• Pharmacy and stock management
Clinical Research Associate
Covance
Sydney, Australie
2019.09 - 2020.06
• Pharmacy and stock management
• RTSM
• EDC
• Site training and oversight
• ICH-GCP compliance
Clinical Trial Assistant
ICON plc
Sydney, Australie
2017.05 - 2019.03
- Gestion documentaire multisponsors (Pfizer, BMS, Regeneron)
- CTMS
- TMF / eTMF
- Facturation
Coordinatrice RTSM
Johnson & Johnson
High Wycombe, Royaume-Uni
2016.01 - 2016.06
- Budget management complete review
- Administrative coordination
- Meeting organisation
- Minutes collection and dispatch
- Travel management
Clinical Trial Assistant
PhlexGlobal
London, Royaume-Uni
2011.08 - 2015.10
- Review of full documentation TMF accuracy before archival
- Budget review,
- Site Set-up before SIV.
- Documents collection prior to Ethics submission
Clinical Trial Assistant – Oncologie
Wyeth - Pfizer / Roche
Paris, France
2008.10 - 2011.08
- Soumissions éthiques (études, amendements, SUSARs)
- Suivi budgétaire et rapprochement factures CRO/ fournisseurs
- Interface opérations cliniques / réglementaires
- Support mise en place et suivi centres (SIV)
- Gestion ISF / TMF
Skills
- RECIST 10,
- CTCAE 50,
- Medidata Rave,
- Clinflash,
- Veeva Vault,
- CTMS,
- RTSM / IRT / IWRS,
- MS Office
Certification
- 2025 –Project Management Training certificate– TigerMed Sydney Australia
- 2025 – ICH-GCP E6 R3 – TigerMed Sydney Australia
- 2019 – Monitoring Excellence Academy (CRA) – Covance Sydney Australia
- 2016 – Essential GCP & Intro to Monitoring – ARCS Sydney Australia
- 2014 – Ultimate CRA Development – Ecole Pharma (UK)
- 1995 – High School Certificate 1995 Saint Marie Brussels
Languages
French
Native
English
Fluent
Timeline
Senior Clinical Research Associate
TigerMed CRO
2022.05 - 2025.11
Clinical Research Associate
PPD
2020.08 - 2021.10
Clinical Research Associate
Covance
2019.09 - 2020.06
Clinical Trial Assistant
ICON plc
2017.05 - 2019.03
Coordinatrice RTSM
Johnson & Johnson
2016.01 - 2016.06
Clinical Trial Assistant
PhlexGlobal
2011.08 - 2015.10
Clinical Trial Assistant – Oncologie
Wyeth - Pfizer / Roche
2008.10 - 2011.08