Life science, strong clinical trials background with advanced project management skill
Mes compétences :
Project Management
Budget Management
Team Management
Vaccines Development
Matrix Management
GCP
Entreprises
Sanofi Pasteur MSD
- Head of planning & project mngt
Paris2015 - maintenantReporting to VP Development, my mission is to:
- Implement PPM best practices, metrics/dashboards and develop strong collaboration relationship across Development organization
- Manage Dev functions activities portfolio & projects portfolio, implement tool to provide visibility and facilitate decision making at function/project and Executive levels
- Plan and execute department-wide projects that align with business priorities
Sanofi Pasteur MSD
- Head of Clinical Operations
Paris2013 - 2015My mission is to oversee the clinical trials execution in order to deliver clinical data with the best Quality/Cost/Time balance.
I achieve my mission by
- leading and developing the clinical operations staff (Clinical Trial Managers and Clinical Trial Assistants)
- providing strategic direction for out-sourcing
- developing and implementing processes and systems related to operational activities.
Paris2010 - 2013Fully accountable for Timelines, Quality and Cost of International vaccines clinical trials.
Covered countries: Belgium, Canada, Denmark, Finland, France, Germany, Italy, Spain, Sweden, and UK.
Acting as a Project Leader in a matrix organisation, I am in charge of:
▫ Development of Protocol, Project sizing and Planning,
▫ Supervision of study documents development such as Informed Consent Form, Case Report Form, Diary Card, Study Specific Procedures and Guidelines,
▫ Regulatory submissions and contracts negotiation,
▫ CROs selection and study budget forecast and management (ranging from 1.5 to 5 million € per study),
▫ Country affiliates and shareholders liaison, supervision of investigational sites selection,
▫ Organisation and Chair of Investigators Meetings, participation to CRA training.
Paris2005 - 2010Project coordination in a matrix organisation:
▫ Development of study documents,
▫ Project Planning,
▫ Development of Study Specific Procedures and Guidelines,
▫ Regulatory submissions preparation,
▫ CROs selection and study budget monitoring,
▫ Investigational sites selection,
▫ Participation to CRA training and Investigators Meetings.
Sanofi Pasteur MSD
- Central CRA
Paris2003 - 2005▫ Global coordination of activities related to monitoring and management of monitoring CRO.
▫ Development of study documents
Pharmascan
- CRA
2000 - 2003Phase I to IV clinical trials monitoring and coordination:
▫ Several therapeutic areas such as dermatology, gynaecology, ophthalmology, paediatric,
▫ Different medical structures such as hospital, clinical investigation centre (CIC) and private practices