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Summary

Interested in Public Health and Epidemiology, expertise in infection Disease in Developing Countries. Participated with the Ebola Outbreak Response Team for the implementation of the Vaccine trial in Sierra Leone: STRIVE Global Health Professional with experience in Developing Countries, Strong Interpersonal skills and capable of working on an multi-cultural environments. Clinical Trials Specialties: Phase II, III, IV, Registry, Observational, Pre-Market Drug and Post-market Drug long term follow up Oncology (Chronic Lymphocytic Leukemia, Small Cell Lung Cancer, Colorectal cancer, Breast Cancer, Pancreatic Cancer) Rheumatology (Arthritis Rheumatology) Infectious Diseases (HIV Study) Chronic Obstruction Pulmonary Disease (COPD) Medical Device (TAVI Valves, BMS, DES, Neuromodulation, Coronary and Renal Denervation, Pacemaker) Alzheimer's Disease (CNS) Dermatology (Severe Chronic Plaque Psoriasis) Renal Hypertension, Neuromodulation on lower back Pain Periperal Vascular Diseases Pediatric studies (Rare Orphan Diseases) and Batten Diseases Orthopedic (Hip and Knee surgery) Deep Vein Thrombosis and others VTE Interventional Cardiovascular

Experiences

Current Experience

  • Clinical Health Consultant-Ebola Outbreak in Sierra Leone
    Since March 2015
    Ebola Virus Vaccine project in Sierra Leone: STRIVE Responsibilities: Informed consents, SOPs, Monitoring Plan and other appropriate documentation preparation. Monitors clinical trials to ensure subject safety and compliance with the study protocol, FDA regulations and ICTVGCP Guidelines. In Charge of the Immunogenicity Sub-Study with CDC staffs and Dr. James Lange Conduct site assessment, initiation, routine, and close-out monitoring visits, Complete accurate monitoring visit reports Develops training materials and conducts training for study implementation based on company policies and SOPs Collaboration with National Scientific Leadership team and 350 Data entry clerks through a sub contract with FHI360 and Sierra Leone College of Medecine and Allied Health Sciences (COMAHS) Serve as a daily point of contact between CDC, eHealth, FHI360 and Connaught Hospital Staff. Daily project reporting and documentation Study in collaboration with Center of Disease Control and Prevention (CDC) Sierra Leone was declared by WHO Ebola-Free on November 07th 2015.

Past Experience

  • Clinical Trials Consultant
    July 2014 --- December 2015
    Since July 2014: Phase II/III clinical trials for sleeping sickness (Human African Trypanosomiasis) in Democratic Republic of Congo,including several trips in Congo. Studies in Collaboration with DNDi

  • Clinical Research Consultant
    September 2008 --- December 2015
    International Monitoring and Project Management in Europe and Africa. EDC Knowledge (Inform, Oracle and Medidata), Clinphone, Phase Forward, Impact, Clarix and Quest. Accountable for start-up site activities including site timelines, study visits, site selection, site initiation, site management, study drug management. Responsible for managing sites and vendor budget activities: Central Depots, CROs, Randomization center, Central imaging, Central Lab and Core Lab. Develops reviews and approves regulatory and other required study documents for GCP compliance. International Project Manager: Phase III Infectious Disease (HIV patients) study in Europe: France, United Kingdom, Italy, Poland, Germany, Spain and Belgium. Lead CRA: Medical Devices sponsors (BMS, DES, Neurovascular, Renal Denervations, Tavi Valves, Neuromodulation, Pacemaker) Monitor/SCRA: Phase III in Cardiovascular in France, United Kingdom, Germany, Italy, Spain, Belgium and Poland. Study submission to Ethics Committees, CA, monitoring and negociated study budget per site and with Investigator Contracts management. Source Data Verification on EDC ( Inform, Medidata, Oracle) Monitor: Medical Device study in Cardiovas with Transcatheter Aortic Valve in France and Italy (13 sites in total) Monitor/SCRA: Chronic Obstruction Pulmonary Disease Phase III study in France Responsable for submission to AFSAPPS, EC, CNIL and CNOM. Monitor: Phase III multicenter on Chronic Plaque Psoriasis for France and Italy Monitor for Drug Neglected Diseases in Africa.

  • Senior Clinical Research Associate (CRA)
    August 2006 --- September 2008
    Review the status of TMFs (Trial Master File) in Clinical Operations for different projects and take action on Audit findings. Review documents in Clinical Operations (monitoring guidelines, operational manual) Phase II study on Rheumatology: -Pre study visit in France, Italy, Belgium -Submission to Ethics Committee -Contracts negociation with Investigator -Budget management with sites -Training on EDC Observational Phase study in Heart Transplant: -Contract Management -Financial negociation with investigators for study budget -Monitoring in France, United Kingdom, Spain, Italy and Germany -Training site on EDC system -Queries reconciliation Phase IV study in Small Cell Lung Cancer: Pre study Visit In France and preparation of site Reports Investigator Selection Submission to EC Contracts Preparation and budget negociation per site Investigator budget and financial investigator contracts preparation collecting all essentials documents participated in Conference call with Sponsor EDC training with Inform

  • Clinical Study Nurse (SN)
    March 2006 --- August 2006
    Oncology Services: Evolved in 7 Oncology studies from phase II to Phase IV Ethics Committee Submissions, Preparation of Study site contracts Investigators contracts Tracing Study payments Collecting study essentials Documents and scanned them on ELARA Manage preparations for and follow-up from committee meetings including coordination of agenda. Prepare background/supporting documents, documents the proceedings, draft and distribute minutes upon approval of the committee co-chairs and follows up on action items. Managing SUSAR for day to day and resolved any queries

  • Clinical Study Nurse (SN)
    January 2005 --- January 2006
    Helped CRA`s with differents studies preparation I have also worked with the CoSource Department and handle Contract with Sponsor

Knowledge

LinkedIn Assessment :
Clinical trialsGCPCROClinical monitoringClinical DevelopmentEDConcologyClinical researchMedical DevicesPharmaceutical IndustryDrug DevelopmentCTMSmanagementICH-GCPProtocolClinical Study DesignPharmacovigilanceClinical operationsRegulatory submissionsTherapeutic AreasBiotechnologyMedical writingClinical Data ManagementHypertensionRegulatory affairsCardiologyNeurologyProject ManagementInformSOPRheumatologyTrainingMedical affairsCellPediatricsStart-upsPublic HealthInfectious diseasesEpidemiologySOP

Skills and Expertise

Self Assessment :
Interested in Public Health and Epidemiology expertise in infection Disease in Developing Countries. Participated with the Ebola Outbreak Response Team for the implementation of the Vaccine trial in Sierra Leone: STRIVE Global Health Professional with experience in Developing Countries Strong Interpersonal skills and capable of working on an multi-cultural environments. Clinical Trials Specialties: Phase II III IV Registry Observational Pre-Market Drug and Post-market Drug long term follow up Oncology (Chronic Lymphocytic Leukemia Small Cell Lung Cancer Colorectal cancer Breast Cancer Pancreatic Cancer) Rheumatology (Arthritis Rheumatology) Infectious Diseases (HIV Study) Chronic Obstruction Pulmonary Disease (COPD) Medical Device (TAVI Valves BMS DES Neuromodulation Coronary and Renal Denervation Pacemaker) Alzheimer's Disease (CNS) Dermatology (Severe Chronic Plaque Psoriasis) Renal Hypertension Neuromodulation on lower back Pain Periperal Vascular Diseases Pediatric studies (Rare Orphan Diseases) and Batten Diseases Orthopedic (Hip and Knee surgery) Deep Vein Thrombosis and others VTE Interventional Cardiovascular

Education

  • Master’s Degree in MSc. in Control of Infectious Disease in Developing Countries from London School of Hygiene and Tropical Medicine, U. of London in 2018
  • in from Georgia State University in 2004
  • in from Universite Sorbonne Nouvelle Paris III in 2004

Training and Certification

  • CITI GCP TRAINING in 2015 Certification

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Native
Italian
Full Proficiency
Spanish
Full Proficiency

Area / Region

Paris, France

Others

Driving License
  • No