À propos de Sandra
Senior Clinical Project Manager with 10 years of experience in global clinical trials and 6 years in international project and team leadership. Proven track record in delivering complex multinational studies across Europe and international regions, with full ownership of study lifecycle, multimillion-euro budgets, and CRO governance. Recognized for consistent on-time, on-budget delivery, proactive risk mitigation, and effective cross-functional leadership in high-stakes environments (up to 35+ FTE).
Français
Bilingue ou natif
Anglais
Capacité professionnelle complète
Portugais
Capacité professionnelle limitée
En télétravail uniquement
Travaille majoritairement à distance
Expériences
- APHPClinical Study Manager - Global Clinical Trialsjuillet 2019 - Aujourd'hui (6 ans et 11 mois)Paris, France• Full accountability for end-to-end study lifecycle management (start-up to database lock and close-out)• Manage multi-million € study budgets, including forecasting, resource allocation and financial tracking• Oversee full-service CRO partnerships, including milestone tracking, KPI monitoring and performance management• Chair governance and cross-functional meetings with sponsors, vendors and stakeholders• Leadership of 35+ FTE cross-functional teams (Clinical, Data, Regulatory, CRO) in global environments• Deliver multiple global trials on time and within budget• Reduce operational risks through proactive risk management and CAPA strategies• Ensure continuous inspection readiness and regulatory compliance (ICH-GCP)
- APHPClinical Research Associate Leadmai 2017 - juin 2019 (2 ans et 1 mois)• Lead CRA activities across multiple European countries• Supervise site initiation, monitoring activities (on-site and remote), close-out visits and ensure quality and compliance across sites• Ensure TMF quality control and completeness• Identify and manage protocol deviations• Train study teams on GCP compliance and deviation reporting• Support eCRF testing and data quality oversight• Lead TMF quality control and supported audit readiness
- APHPQuality Assurance Leadmai 2017 - juin 2019 (2 ans et 1 mois)Internal audits & TMF compliance• Conduct internal audits and TMF quality reviews• Develop and implement internal procedures aligned with ICH-GCP requirements
Recommandations
Soyez le premier à recommander Sandra
Contribuez à la réussite de ce freelance en partageant votre expérience de collaboration avec lui.
Ces profils de freelance correspondent également à vos critères
Agatha Frydrych
Backend Java Software Engineer
4.7
(3)
2
Baptiste Duhen
Fullstack developer
4.6
(4)
5
Amed Hamou
Senior Lead Developer
4
(2)
7
Audrey Champion
Web developer
4.3
(3)
4
Formations
- DIU FARC-TEC – Clinical Research Associate and Study Coordinator TrainingSorbonne University2017DIU FARC-TEC – Clinical Research Associate and Study Coordinator Training
- Master IISorbonne University2016Master II