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Gianluca Ceravolo

Gianluca Ceravolo

Clinical trial Administrator

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location of Gianluca CeravoloGreater Milan Metropolitan Area

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  • Timeline

  • About me

    Territory Manager | Structural Heart | Abbott | Mitraclip | Tendyne | TEER | TMVR | Structural Heart | Heart Failure | Cardiac Implantable Electronic Devices | Cardiac Electrophysiology

  • Education

    • Liverpool school of english

      2017 - 2017
      Certificate of attendance and progress, General English Advanced level

      8 weeks course in advanced level

    • Università di Roma Tor Vergata

      -
      Bachelor's degree Ingegneria biomedica/medica

    • Politecnico di Torino

      2014 - 2016
      Master's degree Biomedical Engineering

      Activities and Societies: Main courses: Mechanics applied to Biomedical Systems, Design of Prostheses and Artificial Organs, Active implantable devices, Bioimaging, Electronic Bioengineering and Electrical Security, Biomedical signal processing, Bionanotechnologies, Cardiovascular system biomechanics, Biomedical data Classification and Interpretation, Experimental biodynamics, Fluids Biomechanics. Title of the thesis’s project: “Activation and maintaining of Hyperemic response in the treatment with intermittent pneumatic compression devices”. Programming of three different control logics of a IPC (intermittent pneumatic compression) prototype for treating the lower limbs, developed at Politecnico di Torino, entirely managed by microcontroller Arduino Mega.Development of two experimental protocols, where twenty healthy and willing subjects were enrolled. Physiological parameters… Show more Title of the thesis’s project: “Activation and maintaining of Hyperemic response in the treatment with intermittent pneumatic compression devices”. Programming of three different control logics of a IPC (intermittent pneumatic compression) prototype for treating the lower limbs, developed at Politecnico di Torino, entirely managed by microcontroller Arduino Mega.Development of two experimental protocols, where twenty healthy and willing subjects were enrolled. Physiological parameters monitoring, such as arterial and venous flow (with ecoDoppler probes) and oxygenation levels of the tissues treated by compressions (with NIRS probe).Signal acquisition, signal processing; data analysis and data management. Weekly report on the outcomes of experimental tests. Teamwork. Show less

  • Experience

    • Alvimedica

      Mar 2017 - Oct 2017
      Clinical trial Administrator

      Objective: To guarantee the correct execution of the clinical investigations collaborating in the drawing up of Clinical Investigation Plans and Reports.Activities:▪ Specific training and knowledge of the principal implantable stents devices produced by the Company▪ Experience in clinical trials with attention on the implantable devices▪ Knowledge of the Medical Devices Directives 93/42▪ Good knowledge of GCP and the existing legislation in the field of clinical trials (ISO 14155, MEDDEV) ▪ Control of the progress of the clinical trials and data management▪ Collaboration in the drawing up of the Clinical Investigation Plans, Clinical Reports, Clinical Evaluation Reports and Post Market Surveillance Reports ▪ Statistical Analysis performed together with the Biostatistician▪ Knowledge of the System organ classes classification (MedDRA), necessary to classify the SAE (Serious Adverse Event) declared during the clinical trials▪ Remote monitoring, according to the Monitoring plan, on the e-CRF (Case Report Form) in order to check data completeness and verify the existence of protocol deviations▪ Management and research of relevant scientific publications▪ Preparation of presentations for internal and external use▪ Management of transversal projects in collaboration with QA and R&D Departments ▪ Collaboration in editing and revision of Clinical Procedures and SOPs Show less

    • BIOTRONIK

      Nov 2017 - Oct 2020
      Clinical Specialist

      CRM - Cardiac rhythm management (pacemaker, defibrillator, CRT).Electrophysiology.Clinical project management

    • Impulse Dynamics

      Oct 2020 - May 2022
      Senior International Clinical Engineer

      Heart failure medical device.CCM (Cardiac contractility modulation)

    • Abbott

      May 2022 - now

      Tendyne (TMVR)Mitraclip Tendyne (TMVR)Mitral valve replacement

      • Territory Manager - Structural Heart

        Apr 2023 - now

      • Senior International Therapy Specialist

        May 2022 - Apr 2023

  • Licenses & Certifications

    • Ielts exam

      British Council

    • ISO14155

      WMDO - World Medical Device Organization