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Experiences

Current Experience

  • Lead Clinical Research Associate (LCRA)


    Since April 2014

    CRA teams oversight, Phase III/observational studies/rmp surveys, in charge of europe, russia, middle-east and australia, from feasibility to close-out, including : - project Training - monitoring activities/status reporting - visit reports review - CRA performance tracking/metrics - primary liaison for Clinical monitoring issues, working closely with the Project Manager - participation of internal and sponsor project meetings - creation and maintenance of clinical project documents in collaboration with the Project Manager - mentoring of cras / co-visits

    CRA Teams Oversight, Phase III/Observational studies/RMP surveys, in charge of Europe, Russia, Middle-East and Australia, from feasibility to close-out, including : - project training - monitoring activities/status reporting - visit reports review - CRA performance tracking/metrics - primary liaison for clinical monitoring issues, working closely with the Project Manager - participation of internal and sponsor project meetings - creation and maintenance of clinical project documents in collaboration with the Project Manager - mentoring of CRAs / co-visits

Past Experience

Personality

Self Assessment :
AdaptabilityCollaborationCommunicativeCoordinationDiligenceEfficiencyFlexibilityIndependenceOrganizationProactivityProblem solvingResponsibilitySelf-discipline

Knowledge

Self Assessment :
Adverse Events (AE)CancerCardiologyClinical monitoringClinical operationsClinical researchClinical trial audits and inspectionsClinical trial managementClinical Trial Management System (CTMS)CNSCommunication SkillsComplianceCRFCROCross-functional team leadershipDiabetesDrug AccountabilityEarly development stageeCRFEDCEfficacy trialsEndocrinology and metabolismEnglishEpidemiologyEthics submission and approval processGastroenterologyGood Clinical Practice (GCP)HematologyICH guidelinesInfectious diseasesInformed Consent DocumentsInternational Project ManagementIVRSMedical DevicesMicrobiologyMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordNephrologyoncologyOutlookPatient Reported Outcome Measures (PROMs)Patient Screening and RecruitmentPharmaceutical IndustryPhase IPhase IIPhase IIIPhase IVPresentation SkillsProblem SolvingProject CoordinationProject ManagementPsychiatryPulmonary diseasesQA complianceQuality of Life (QoL) outcomesRegulatory submissionsSafety reportingTeam BuildingTeachingUrology
LinkedIn Assessment :
eCRFEssais cliniquesClinical trial managementICH-GCPCROClinical trialsClinical monitoringFeasibility StudiesPhase 1Phase 2Phase 3Phase 4Compliance OversightRegulatory submissionsProject PlanningRisk ManagementBudget ProcessProject CoordinationGantt ProjectCTMS

Skills and Expertise

Self Assessment :
project managementCommunicate with sponsorCommunicate with investigator Guide students Monitor a clinical studyApprove monitoring reportsAssist with site trainingAttend investigator meetingCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Communicate effectively on different company levelsConduct post-marketing surveillance studyCoordinate projectsCoordinationCreate study documentsDevelop training materialsEnsure good clinical practice (GCP)Ensure data integrityEnsure data consistencyIdentify investigatorsIndentify clinicians to conduct clinical trialsInitiate clinical trials Interact with CROsInteract with KOLInteract with regulatory stakeholdersManage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Manage contractors Manage regulatory activitiesMonitoring subject complianceOral presentationPlan work to meet objectives and deadlinesPrepare regulatory documentsRegulatory submissionsRespond to audit findingsReview monitoring reportsReview study protocolsSelect investigatorsSet up a clinical studySupervise clinical monitorsUnderstand protocolsUpdate Clinical Trials Management System (CTMS) Verify dataWork collaboratively with the other members of the clinical research team Work cross-functionally

Education

  • Attaché de Recherche Clinique in Recherche clinique from Sup'Santé in 2004
  • DESS Contrôle des médicaments et des cosmétiques in Contrôle Qualité Industrie Pharmaceutique from in 2002
  • Maîtrise de biologie et microbiologie in biologie from in 2002

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency
German
Elementary Proficiency
French
Native

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    Clinical Trial Manager (CTM) Clinical Trial Coordinator (CTC) associate Clinical Project Manager Clinical Project Leader Clinical Research Coordinator Clinical Research Manager CRM Team Leader
  • Positions I am NOT interested in:
    Senior Project Manager (PM)
  • Locations I am interested in:
    France Strasbourg, France
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    No

Area / Region

Strasbourg, France

Others

Driving License
  • No

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