2011 - maintenantPharma Development, Operations and Clinic
Global study Manager in international Studies.
Working on Haematologic cancer Area.
Responsible for study management activities on 2 phase III studies.
Hoffman La Roche LTD
- Global Study Associate
2008 - 2011Pharma Development, Operations and Clinic
Associate in the Operational clinical team in international Studies.
Working on Haematologic cancer Area.
Responsible for Feasibilities, Sites Selection, Vendors Selection, Contract and Scope of Work negociation, Drug Management, Supplies management. Primary contact for Monitors in the countries.
Responsible for HQ documentation and HQ communication.
CHU de Poitiers
- Study Coordinator / Clinical Research Associate
Poitiers2003 - 2007From January 2003 to March 2007 - University Hospital of Poitiers - Clinical Research Assistant/ Study Coordinator,
Intensive Cares Unit (from December 2004 to March 2007)
Hepatology and Gastroenterology Unit (from January 2003 to January 2006)
Microbiology Laboratory (from January 2003 to December 2004)
- Management of multicentric epidemiological studies (Hepatitis C, Stress Ulcer, Renal Transplant, Renal Insufficiency)
- Preparation and tracking of clinical trial documentation (protocol, case report form)
- Study initiation in investigational centers, monitoring visits in compliance with ICH-GCP and local regulations
- Collaboration with investigators in clinical centers and with industrial sponsors or CRO for study design and for management of trials on-going in the unit
- CRF completion
- Database development
- Statistical analysis
Research Management Department (from May to August 2005, determinate period for replacement of a pregnant person)
- Management of Ethic’s committee and Authorities submissions for all clinical studies promoted by university hospital of Poitiers (insurance, adverse events, amendments)
- Relation with industrial sponsors or CRO for research contracts
- Relation with Hospital’s CRA and with all administrative hospital units
CHU de Dijon
- Attachée de recherche Clinique / Chef de Projet
Dijon2001 - 2003From May 2001 to January 2003 - Project Manager - University Hospital of Dijon - Quality and Research Department
- Management of Ethic’s committee and Authorities submissions for all clinical studies promoted by university hospital of Dijon (insurance, adverse events, amendments)
- Regulatory support for medical staff
- Project financial control
- Relation with industrial sponsors or CRO for research contracts
- Writing of standard operating procedures
- Reports writing
- Coordination of a multicentric clinical trial who compare two surgical techniques in lung’s cancer
