Audrey Duflot
Clinical Trial Manager @OM Pharma
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WORK HISTORY
Clinical Trial Manager @OM Pharma
Oversight and management of 2 studies : Phase I study in Germany (monocentric) and Phase II study in US (30 sites), Europe (4 sites), and Australia (3 sites)- Development and operational design, planning of budget and timelines, feasibility assessments and initiation of clinical trial protocols and programs - Leads internal cross functional Clinical Study Teams responsible for conducting global clinical trials to ensure project deliverables are executed on time within budget with full oversight - Manages external services providers : CROs, vendors and subcontractors - Ensures CTs are conducted according GCPs and all applicable regulations- Contribution to essential documents, reviews and manages audits/inspections- Accountable to track trials KPI and improve trial performance- Responsible for budget management, evaluation of project budget variances/scope changes- Manage relationships with investigators, KOLs, pharmaceutical partners and suppliers in clinical development programs- Development and implementation of process improvement to ensure regulatory/ legal compliance - Support of Clinical Operations tools and departmental development- Speaker for the DAS - Clinical Trials and Drug Development Courses at University of Geneva
EDUCATION
Lycée Madeleine Michelis
Baccalauréat, Scientifique
University of Montpellier
IUP - Master Ingénierie de la Santé, Management des Opérations Cliniques et Data Management
Université de Picardie Jules Verne (Amiens)
Première Année Commune des Etudes de Santé
Université de Picardie Jules Verne (Amiens)
Licence Ingénierie de la Santé, Biologie Humaine et Technologies de la Santé
SKILLS
ABOUT AUDREY DUFLOT
Clinical Trial Manager - OM Pharma
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