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inVentiv Health Clinical
- Director, Clinical Research - Late Stage
Nanterre
2014 - 2015
* Portfolio Director EU and Line Manager of Sr PM/ PD ;
* Oversee interdisciplinary Late Stage research Programs
* Represent the company to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively
* Ensure all studies within a program are conducted to reflect the observational studies and client specific requirements
* Apply study specifics learning across assigned portfolio of studies/ clients
* Ensure and maintain in depth observational/ non-interventional projects and client specific knowledge and expertise for the assigned Portfolio
* Contribute to the development of Project Development Plans
* Ensure programs of studies are conducted in compliance with relevant regulations and relevant SOP's
* Plan, coordinate and present at internal and external meetings including conferences and professional organizations
* Participate in bid defense meeting as required ;
* Lead operational input to proposal development and pricing, including proposed operations strategy at a program level
* Drive performance improvement and operations efficiencies at a program level
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inVentiv Health Clinical
- Associate Director, Late Stage
Nanterre
2011 - 2014
* Global oversight of non-interventional projects in Europe and Latin America and Line Manager of Lead CRA and PM
* As Project Director, managed interdisciplinary research projects, leading the operational team to ensure on-time, on-budget performance
* Represented the company to the customer, ensuring satisfaction levels are maintained and project deliverables are communicated effectively
* Ensured all studies are conducted to reflect the Late Stage studies and client specific requirements
* Applied study specifics learning across assigned studies/ clients
* Ensured and maintained in depth Late Stage projects and client specific knowledge and expertise for the assigned studies
* Contributed to the development of Project Development Plans
* Ensure studies are conducted in compliance with relevant regulations and relevant SOP's
* Reviewed and developed protocols and Case Report Forms (CRFs)
* Participated in proposal meetings with potential clients and in bid defense meeting, as required
* Reviewed Tables and Listings generated from study data and Observational Study Reports
* Supervised, Trained, and mentored clinical staff on monitoring, SOPs and procedure
* Mentor Lead CRA and Project Managers on SOPs, OGs and policies
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inVentiv Health Clinical
- Manager, Phase IV Development
Nanterre
2007 - 2011
* As Project Manager, managed interdisciplinary clinical research projects, leading the clinical team to ensure on-time, on-budget performance
* Supervised, trained, and mentored Clinical Research staff ;
* Approved investigator study budgets and contracts ;
* Reviewed and approved regulatory and administrative documents from investigator sites
* Reviewed and developed protocols ;
* Reviewed and approved Case Report Forms (CRFs) ;
* Planned, coordinated, and presented at Investigators' Meetings
* Participated in proposal meetings with potential clients
* Reviewed Serious Adverse Event (SAE) reports ;
* Reviewed and approved monthly client invoices ;
* Prepared project management reports for clients, project personnel, and iHC management
* Reviewed and approved monitoring trip reports ;
* Reviewed Tables and Listings generated from study data ;
* Authored Clinical Study Reports ;
* Trained CRAs on monitoring, internal procedures, and query resolution
* Mentored Senior CRAs on project management procedures and policies ;
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DOCS International
- Clinical Scientist Consultant
2006 - 2007
* Managed Phase II and III studies ;
* Oversaw Regional offices activities for each Project ;
* Reviewed Trip Report
* Reviewed Clinical Data
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Fovea Group
- International Project Manager
2003 - 2006
Fovea Group, Contracted to Solvay Pharmaceuticals
* Managed Phase IV and Pharmaco-epidemiological Studies (28 countries, 60.000 patients; 13 countries, 2800 patients)
* Performed customer service, quality, timelines and met financial targets
* Performed documents design: Protocol, Case Report Form, Questionnaires, regulatory and communication
* Led and motivated a cross-functional project team ;
* In collaboration with the relevant managers and providers, coordinated the activities of implementation, follow-up, data management and publication
* Performed customer relationships management to help secure new and repeat business ;
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Fovea Group
- Quality Assurance Manager
2002 - 2006
* Oversaw the Company Quality Management System and ensured full compliance with ISO 9001:2000 Standards and regulatory requirements
* Designed and implemented Standard Operating Procedures ;
* Organized and managed Regulatory Intelligence ;
* Trained and evaluated the collaborates ;
* Managed audits agenda and auditors team ;
* Led audits (Phase I to -IV and pharmaco-epidemiological studies)
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Fovea Group
- CRA I, II, Sr CRA
1999 - 2003
Fovea Group, Contracted to Takeda, Abbott, AstraZeneca, Galderma and GlaxoWelcome
As Clinical Research Associate (CRA),
Worked with Specialists and General Practitioners
Performed documentary and regulatory management and project management
Performed feasibility studies, center pre-screening; investigators phoning boost and project coordination
Performed project implementation
Initiation, monitoring and close-out visits
