Site network Manager Marseille 12June 2015 --- December 2015
work with quintiles project stategy and project teams to enhance the overall Patient Recruitment and site relartionship effort in rhône-alpes region.
working on site selection to be sure to propose the right study to the right site (regarding infrastructure, capabilities, pipelines...).
main point of contact, as referent manager for astra-zeneca france.
Clinical Research Manager Marseille 12August 2009 --- May 2015
fieldbased in marseille from sept 2009 to dec 2010 : management of 15 fieldbased cras all located around lyon, montpellier , marseille and nice.
in charge of the recruitment of my team : 6 persons in sept 2009 to 15 persons in dec 2010.
creation and management of the ssv team : 5 persons dedicated to pre-study visit and selection visit in france
Clinops CRA resourcing manager FranceJanuary 2011 --- May 2014
responsible for allocation of cras in france based on profiles of the current workload, skills and therapeutic expertise of each person.
creation of tools, processes and reporting method for this activity : 100 cras - > 800 sites - > 400 projets
CRM Customer managed Marseille 12October 2007 --- August 2009
fieldbased in marseille management of 25-30 cras and ctls who are sponsor office based.
collaboration with pfizer, sanofi, baxter, lfb, amgen.
Senior Clinical Research Associate (CRA) Marseille 6May 1999 --- June 2006
fieldbased in marseille management of studies in south est region of france : full responsibilities of monitoring activities from selection visit to close out visit.
monitoring :general medical doctors, specialists, and Hospital.
CRA / Sr CRA Marseille 5, Marseille, FranceOctober 1991 --- April 1999
CRA fieldbased in marseille.
working as national CRA for fdm pharma. 3 names for this company located in sophia antipolis between 1991 and 1999 : data master - fdm pharma and the valorum. this company has been closed by law decision in april 1999.
monitoring : general medical doctors, Hospital and medical specialists.
AdaptabilityAuthenticityCollaborationCommunicativeCuriosityEfficiencyInterest in knowledgeOptimismOrganizationProblem solvingProactivityReaction to stressService orientedSociabilityTrust
Diabetes Phase IAdverse Events (AE)CancerCAPACardiologyClinical monitoringCNSCoachingCommunication SkillsContract negotiationCROCTMSCustomer ServiceDermatologyEarly development stageEDCEndocrinology and metabolismGastroenterologyGeneral MedicineGood Clinical Practice (GCP)Gynecologic oncologyHospitalsInternal medicineInterventional CardiologyKOL managementmanagementMetabolismMicrosoft OfficeNephrologyNeurologyNursingoncologyOutsourcingPhase IIPhase IIIPhase IVProblem SolvingProcess improvementPsychiatryQuality ManagementRecruitingRespiratoryRheumatologySchizophreniaSerious Adverse Event (SAE)Supervising CRAsTeam BuildingTeam ManagementTeamworkTime ManagementTrainingUrologyWomens Health
Skills and Expertise
Assure medical quality Design case record forms Guide students Interact with nurses Interact with physicians Monitor a clinical study Use content management systemsAct as the main line of communication between the sponsor and the investigatorAdverse event reportingAlzheimerApprove monitoring reportsAssess quality process issuesAssign activitiesAssist with site trainingAttend investigator meetingCoach and provide guidance to clinical staff.Collaborate with medical teamCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with principal investigatorCollaborate with project teamCommunicate with investigatorCommunicate with sponsorConduct close-out visitsConduct site initiationConduct studiesCreates a collaborative team environmentData entryData verificationDocument employees training requirementsEnsure good clinical practice (GCP)Gastrointestinal diseasesIdentify and provide training to trial team and associated staffIdentify growth / improvement potentialIdentify investigatorsImplement ProcessesInteract with KOLInteract with nursesLead teamsLiaise with doctors and other professionals throughout the studyMaintain strong relationshipsManage multiple projectsMonitor Key Performance Indicators (KPI's)People managementQuality control processReport non-compliance incidentsSelect investigatorsSelect sitesSite managementSolve problemsTrain StaffUpdate Clinical Trials Management System (CTMS)
Diplôme d'Etat in from Ecole en soins Infirmiers de Chambéry in 1983
MOOC du Management au Leadership agile in from Conservatoire National des Arts et Métiers in 0000
Training and Certification
Management Training - CNAM in 2016 Certification
ICH-GCP Barnett certification in 2014 Certification
ICH-GCP Barnett Certification in 2012 Certification
Diplôme d'Etat d'Infirmière in 1983 Certification