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Summary

• Over 16 years’ experience in the clinical research industry covering a wide variety of phase I to IV studies in Europe and Africa • Thorough understanding of clinical trial processes together with in-depth knowledge of ICH/GCP guidelines and excellent understanding of regulatory requirements • Strong interpersonal skills and a highly motivated team player

Experiences

Current Experience

  • Global Clinical Project Manager (GCPM, GTM)
    Since September 2009
    Project management phase II-III-IV Implementation, tracking and management of clinical operations activities including: study initiation, monitoring supervision, training, quality assurance, ccordination of data management activities, and development of study documents such as CRFs, Project Management Plans, Monitoring Plans, Working tools, Tracking tools and Training tools.

Past Experience

  • Clinical Research consultant in Africa
    January 2008 --- January 2011
    Monitoring visits (selection to close out) and quality control of African sites located in Gabon, Uganda, Burkina Faso for Malaria vaccine trials in adults and children

  • Senior Clinical Research Associate (CRA)
    January 2006 --- January 2009
    Phase I, II and III trials in oncology (solid tumors, prostate, lung, kidney) and phase II trial in cardiology, outsourced to Astellas, Bayer, Ipsen. Regulatory submissions, protocol reviewing, CRF designing, visits of monitoring. European Sites quality control.

  • Homebased Senior CRA
    January 2003 --- January 2006
    Monitoring of several trials in endocrinology, cardiology and ophthalmology. Collaboration with pharmaceutical sales representatives for phase IV initiation meetings

Personality

Self Assessment :
AdaptabilityAttention to detailCommunicativeCompetitivenessCoordinationCreative thinkingCuriosityEfficiencyFlexibilityInterest in knowledgeKindnessOptimismProactivityResponsibilityResult OrientedSelf-confidenceTrust

Knowledge

Self Assessment :
Biochemistry Diabetes Phase I R&D21 CFR Part 11Adverse Events (AE)Budget ManagementCancerCardiologyCardiovascular diseasesClinical monitoringClinical operationsClinical study reportsClinical SuppliesClinical trial audits and inspectionsClinical trial managementClinical Trial Management System (CTMS)CRFCRODrug AccountabilityeCRFEDCEthics submission and approval processFDAGood Clinical Practice (GCP)Good Manufacturing Practice (GMP)ICH guidelinesInfectious diseasesInterventional CardiologyISO 9001IVRSMicrosoft WordOncology Clinical ResearchOutlookOutsourcingPharmaceutical IndustryPhase IPhase IIIPhase IIPhase IVProject ManagementProject CoordinationProject PlanningQuality Control (QC)Regulatory submissionsReport WritingRisk ManagementSerious Adverse Event (SAE)Start-upsStudy approvalsWriting Study Procedures and SOPs

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Create SOPs Design case record forms Develop clinical trial protocols Guide students Interact with nurses Interact with physicians Monitor a clinical study Search literature on clinical trials Use content management systemsAct as the main line of communication between the sponsor and the investigatorApprove consent documentsApprove monitoring reportsApprove patient informationApprove queriesApprove suitability of patient information and consent documentsAssign activitiesassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Archive trial documentation and correspondence.Assess quality process issuesAssist with site trainingAttend investigator meetingAttend seminars, courses and meetings within and outside the companyCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Communicate effectively on different company levelsCommunicate with investigatorConduct close-out visitsConduct site initiationConduct supply issue resolution activitiesConduct the trialConfirm protocol complianceCoordinate projectsCreate study documentsEnsure good clinical practice (GCP)Ethics committee applicationFollow-up of internal auditsGastrointestinal diseasesIndentify clinicians to conduct clinical trialsInteract with CROsInteract with regulatory stakeholdersLead teamsManage budgetsManage multiple projectsOral presentationPersuade clinicians to conduct clinical trialsPrepare responses to health authority queriesproject managementProvide study site fileRegulatory documentationRetrieve study documentsSelect investigatorsTrain on site staffWork with coordination and data management teamsWritten presentation

Education

  • in PhD of Sc "Ethical and legal issues in conducting clinical trials in Developing Countries" from University of Paris XVIII in 2017
  • Certificate in Certificate of Therapeutic Chemistry and Pharmacology from University of Lille 2 in 2007
  • Master’s Degree in Public Health, Ethic and Health Law (Santé publique, éthique et droit de la Santé) from University of Paris VIII in 2007
  • in CESAM: Diploma of Biostatistics in Clinical Research from University of Paris VI in 2006
  • CRA training in clinical research from ClinSearch CRO in 2001
  • Master’s Degree in Biochemistry and Molecular Biology from University of Lille 1 Sciences and Technology in 2001
  • Master’s Degree in PCEM I (medical study) from Université de Picardie Jules Verne (Amiens) in 1998

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Professional Proficiency

Work Preferences

  • Positions I am interested in:
    Clinical Operations Manager Clinical Project Manager (CPM) Clinical Project Leader Clinical Research Consultant Clinical Research Coordinator Clinical Research Manager Regulatory Affairs Consultant Senior Clinical Project Manager (CPM) Senior Clinical Research Associate (CRA)
  • Locations I am interested in:
    France Guinea Ivory Coast
  • Work From Home:
    Yes, 5 Days
  • Work Regime:
    BrightOwl freelancer
  • International:
    Yes

Area / Region

Abidjan, Lagunes, Côte d'Ivoire

Others

Driving License
  • Yes