Senior Manager / Associate Director Issy-les-Moulineaux, France
Since January 2017
Hold a PhD in Sciences and began my career in Clinical Operations 18 years ago. A self-motivated and hardworking manager, line manager of international Clinical Operations Managers and Epidemiologist Operations Managers working in an international environment (Eastern & Western Europe, Asia/Pacific, Latin America, Canada & South Africa) with an established career in the Pharmaceutical industry, specialised in Central Nervous System (CNS).
Able to use own initiative and work as part of a team. Proven leadership skills, including managing and motivating other staff to achieve company objectives. An effective communicator at all levels within an organisation. Good problem solving and analytical skills.
TrainingTeam ManagementTeam LeadershipTeamworkStudy protocolsStudy proposalsStudy approvalsStrategic PlanningStandard Operating Procedure (SOP)Serious Adverse Event (SAE)Screen patientsscienceSchizophreniaRisk ManagementResearchRegulatory submissionsRegulatory ComplianceRegulatory affairsRandomization and blindingQuality of Life (QoL) outcomesQuality Control (QC)Quality AssurancePsychiatryProtocolProject PlanningProject ManagementProject CoordinationProblem SolvingPrinciples and ethics of clinical researchPresentation SkillsPowerPointPhase IVPhase IIIPhase IIPharmacovigilance R&DAdverse Events (AE)Budget ManagementBudget NegotiationBudget ProcessBudgetsCAPAClinical Data ManagementClinical monitoringClinical operationsClinical researchClinical Study DesignClinical study reportsClinical trial audits and inspectionsClinical trial managementClinical trialsClinical Trial Management System (CTMS)OutsourcingComplianceCommunication Skills
Ph.D. in Biochemistry & Molecular Biology from University Pierre & Marie Curie, Paris, France in 1996