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QUINTILES
- Associate CPM Director
Durham
2011 - maintenant
• Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. Implement continuous improvement activities for assigned projects • Define, develop and implement study management plans, together with team assignments and accountabilities • Supervise team performance against contract, customer expectations, and project baselines. Develop recommendations for issue resolution for management and Sponsors • Supervise problem solving and resolution efforts to include management of risk, contingencies and issues. Take accountability for proactive contingency plans to mitigate clinical risk • Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings and own the implementation of appropriate corrective action plans. Manage and oversee the escalation of findings and action plans to appropriate parties • Collaborate with other functional groups within the company to support milestone achievement and to manage study issues and obstacles. Ensure that Sponsor feedback is communicated and conveyed to other functional groups and action is initiated to address • Participate in proposal development, influence the scope and budget development of proposals for new work. Escalate out of scope requests to management • Provide input to line managers of their project team members’ performance relative to project tasks. Recommend team members’ further professional development. Support staff development. • Prepare and present project information at internal and external meetings • Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team
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NicOx
- Senior Clinical Program Manager
Valbonne
2005 - 2011
• Overall responsibility for project management of three Phase I PK studies. • Line management and budgetary control. • Leading global process harmonisation initiatives across the company. • Review of quality audit outcomes to evaluate impacts and take necessary corrective actions to resolve and avoid recurrence of issues. • Participation in the first EMA/FDA joint GCP Inspection in Europe.
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Allergan
- Clinical Project Manager
Courbevoie
2000 - 2005
• Overall responsibility for project management of one Phase I and three Phase III IND studies. • Management of project activities and project team members. • Responsible for managing timelines, quality and costs of project deliverables. • Organisation of Investigators and experts meetings. • Line management of CRAs and CTAs.
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Clipharm International
- Senior Clinical Research Associate
1998 - 1999
• Responsible for site selection, initiation, monitoring and close out of European sites. • Preparation of study documentation such as protocol, informed consent, CRF etc. • Organisation of Investigator meetings. • Line management of CRAs.
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Cordis - NMT Neurosciences
- International Clinical Research Associate
1994 - 1998
• Responsible for site selection, initiation, monitoring and close out of European sites for medical devices studies
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Sanofi Winthrop
- Trainee Clinical Research Associate
1994 - 1994
• Site monitoring and source data verification for a Phase III study.
