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Nadege KambouNK

Nadege Kambou

Project Manager/Lead/Clinical Research Attaché

€800/day
Paris, FR
8-15 years

Average response time: 1 hour

Freelancer profile translated to English.
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About Nadege

Hello,

ARC Monitor in CROs since 2014, I have developed my skills in the management of clinical trials on behalf of local and international Pharmaceutical Laboratories. These are observational, interventional and post-marketing clinical studies, from phase I to phase IV on drugs and medical devices; where the centers followed are located in France, Belgium, Switzerland and the United Kingdom.

I mentor junior ARCs during visits to validate their operational skills and I support ARC Leads in correcting visit reports.

Very motivated, I am involved in clinical trial start-up missions: feasibility, regulatory submissions and I support the Contract department for the establishment of hospital agreements or for the resolution of problems related to payments to Investigator Centers.

Autonomous, rigorous and always cheerful, I make my skills available to research teams for ad hoc support, or on long missions specifically in drugs or medical devices.

Indeed, I am trained in the new European Regulation 2017/745 concerning medical devices and in MEDDEV 2.7/1 rev.4, I provide you with my advice and support in the creation, implementation and monitoring of clinical trials of your medical devices, before and after marketing.

Do not hesitate to consult my site and contact me for any questions about my service offerings or for a quote.

Thank you and see you soon.
Nadège
  • English

    Fluent

  • French

    Native or bilingual

Can work on-site
Paris (up to 50km), Paris (up to 100km), Lyon (up to 100km), Nantes (up to 100km), Lille (up to 100km), Marseille (up to 100km), Toulouse (up to 100km), Montpellier (up to 100km)

Experience

  • FREEARCS PHARMA SERVICES
    Clinical Research Specialist - Monitoring in France, Belgium, Switzerland and UK
    PHARMACEUTICALS INDUSTRY
    June 2014 - Today (12 years)
    Paris, France
    Studies:
    1- Drugs: International, National – Phase I to Phase III. Late Stage, Interventional and Observational Studies
    2- Medical Devices: International, National Clinical Evaluations, Post Marketing Clinical Follow Up (PMCF), Medical Device Regulation (MDR) 2017/745 and MEDDEV 2.7 / 1 rev. 4,

    Clients: International Laboratories and National Institute


    Oversee the sites located in France, Belgium, Switzerland and United Kingdom
    Work with the Clinical Research Team in Burkina-Faso (Africa)


    Fields:
    - 3 years of experience in Pulmonary Diseases (COPD, Idiopathic Pulmonary Fibrosis (IPF)),
    - Oncology (Gastrointestinal Stromal Tumors), Onco-hematology (Acute Myeloid Leukemia (ALM)),
    - CNS (Alzheimer Disease, Parkinson Disease, SLA, Limb Spasticity, Fatty Acid Oxidation Disorders (FAOD))
    - Rare Disease in Hepatology (Wilson Disease),
    - Rhumatology (Rheumatoid Arthritis)
    - Infectious Diseases (Malaria Vaccines),
    - Genetics (Brain Metabolism),
    - Biotherapy in Immunology,
    - Urology (Radical Prostatectomy Dysfunction),
    - Anesthesia (Closed-Loop and feed-back control system)
    - Medical Device: Wound (traumatic disease and surgical indication),
    - Telemedicine in Diabetes
    site activation specialist Feasibility Study monitoring regulatory submissions contract specialist

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Education

  • Master in Sciences and Biology: Cancer Research, Cell Biology
    EPHE
    2014
  • Clinical Research Associate professional training
    CLINACT
    2014

Certifications

  • EU Regulation 2017/745 in Medical Device
    MD101 Consulting
    2020
  • Clinical Evaluation of Medical Devices
    SOLADIS & NEOMED CONSULTING
    2020

Skill set (19)

Categories

  • Other