Experience

Clin'S MD

• France
• Research Services
• 1 - 100 Employee

• CEO & Founder

  • Jan 2022 - Present

  Clin'S MD is a French full-service CRO dedicated to the clinical evaluation of Medical Devices and In Vitro Diagnostic Medical Devices. Contact: hi@clinsmd.com 📌 Clinical Studies - interventional & non-interventional/ pre-market & post-market: design, regulatory file & authorization, sites selection, project management, data management, biostatistics, clinical study report and publication. 📌 Regulatory Affairs : Clinical Evaluation Plan & Report, Writing PMCF Plan, Risk Management Plan & Report and Support to conduct Risk Analysis. 📌 GDPR for the treatment of health data : support for setting-up compliant process and systems. 📌 Trainings - adapted to the client's needs : ✓ Conduct of clinical studies - ISO 14155:2020; ✓ Clinical Evaluation - MEDDEV 2.7/1 rev.4; ✓ Risk Management - ISO 14971:2019; ✓ GDPR applied to health data treatment.



PSL Research University

• France
• Higher Education
• 100 - 200 Employee

• External Lecturer

  • Nov 2015 - Present

  I take part in PSL week's session "Pathologies and Drugs" to introduce pharmacology and clinical research to PSL students. Focus: - Link between physico-chemical properties of the active ingredient of a drug and its PK; - General aspects of PD; - Stages of drug's clinical development; - Methodology of clinical trials; - Regulations of clinical research. I take part in PSL week's session "Pathologies and Drugs" to introduce pharmacology and clinical research to PSL students. Focus: - Link between physico-chemical properties of the active ingredient of a drug and its PK; - General aspects of PD; - Stages of drug's clinical development; - Methodology of clinical trials; - Regulations of clinical research.



Freelance (Self employed)

• Writing and Editing
• 700 & Above Employee

• Clinical Operations & Regulatory Affairs Consultant for Medical Devices

  • Sep 2020 - Jan 2022

  > Clinical Operations - Study start-up (Design of the study and redaction of the protocol; IB and ICF redaction; CRF creation; sites selection; Contracts negotiation; Regulatory authorizations; GDPR conformity); - Study follow-up (TMF and ISF creation and updates; regulatory visits on sites; safety follow-up; data management and data base cleaning); - Data analysis, clinical study report and publication redaction. > Regulatory Affairs - Risk analysis (initial and/or updates); - CER redaction (initial and/or updates). > Training - Introduction to clinical research for medical device development.



Withings

• France
• Wellness and Fitness Services
• 200 - 300 Employee

• Head of Clinical and Regulatory Affairs

  • Apr 2020 - Jul 2020



Greater Paris University Hospitals - AP-HP

• France
• Hospitals and Health Care
• 700 & Above Employee

• Project Manager

  • Apr 2018 - Mar 2020

  Pediatric hepatology and transplantation service led by Pr Emmanuel Jacquemin, localized at CHU Bicètre (AP-HP) has been labellised by French Health Ministry as reference site for several rare liver diseases. Working in strong collaboration with MDs of the service, I help them for national coordination of rare liver disease networks, as well as for setting up and following clinical studies inner the service. > Clinical studies: interventional, non-interventional, national or international studies + registries - Direct management of two study-coordinators of the service; - Study design; - Writing protocols and all essential documents; - Regulatory submissions and follow-up until authorizations; - Close study follow-up in the service; - Data analyses; - Publication redaction. > National coordination of rare liver diseases network: - Organization of executive committee meetings; - Supervision and setting up of national projects in health care and research: creation of a national registry for genetic cholestasis, organization of triannual national multidisciplinary medical staffs for rare liver diseases, ... > Medico-social projects inner the service designed with paramedical staff and patient associations.



Cardiawave

• France
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Preclinical and Clinical Project Manager

  • Oct 2016 - Apr 2018

  Cardiawave is a French start-up that develops a new medical device to treat aortic valve stenosis, using non-invasive therapeutic ultrasounds. > Preclinical project management - Preclinical strategy (aim: obtention of clinical trial authorization and CE mark); - Writing protocols (in vivo and in vitro); - Experimentation follow-up (planning, deviations, reports); - Data management and analysis; - Writing full reports (for Investigator Brochure). > Clinical project management - Clinical strategy; - Writing all essential documents in collaboration of MDs and Regulatory Affairs Director; - Regulatory submissions and contracts negociation (France); - Clinical studies follow-up; - Collaboration with CROs. > Quality : - Writing procedures for preclinical and clinical trials; - Setting up quality procedures in the company. > General: - Strong communication with team in charge of MD development; - Team management.



Greater Paris University Hospitals - AP-HP

• France
• Hospitals and Health Care
• 700 & Above Employee

• Study-coordinator

  • Oct 2015 - Sep 2016

  > Multidisciplinary clinical studies: Radiology, Nuclear Medicine, Oncology, Hepatology and Anapath > 4 Phase III studies, 1 registry : - Inclusion and follow-up of patients, filling eCRFs, SAE notification… - Coordination between services, study setting-up and closure, contracts establishment > 1 translational research ‘First-in-man’ study - Protocol review before submission, CRF creation and study setting-up > Multidisciplinary clinical studies: Radiology, Nuclear Medicine, Oncology, Hepatology and Anapath > 4 Phase III studies, 1 registry : - Inclusion and follow-up of patients, filling eCRFs, SAE notification… - Coordination between services, study setting-up and closure, contracts establishment > 1 translational research ‘First-in-man’ study - Protocol review before submission, CRF creation and study setting-up



CERC (Cardiovascular European Research Center)

• France
• Think Tanks
• 1 - 100 Employee

• Clinical Research Associate Trainee

  • Feb 2015 - Jun 2015

  > Pre- and Post- CE Marking trials of Medical Devices in Interventional Cardiology (4 international trials) > ISO 14155:2011 training > Co-visits (Site initiation, Monitoring and Close-Out visits) in France, Germany and Switzerland > Study Start-up (Submissions to CA, EC (France, Germany and Belgium), CNIL and CNOM) > Safety follow-up (source documents review and CEC preparation) > Documentation maintenance (TMF preparation and filing, ISF preparation) > Pre- and Post- CE Marking trials of Medical Devices in Interventional Cardiology (4 international trials) > ISO 14155:2011 training > Co-visits (Site initiation, Monitoring and Close-Out visits) in France, Germany and Switzerland > Study Start-up (Submissions to CA, EC (France, Germany and Belgium), CNIL and CNOM) > Safety follow-up (source documents review and CEC preparation) > Documentation maintenance (TMF preparation and filing, ISF preparation)



SUP SANTE

• Région de Paris, France

• Clinical Research Associate (Training, SUP SANTE, 3 months)

  • Oct 2014 - Jan 2015

  > GCP Training, > Training in Regulatory Affairs (Submissions to CA, EC, CCTIRS, CNIL and CNOM, CTA, eCTD...), > Medical Training (Cardiology, Neurology/Psychiatry, Oncology, Endocrinology, Infectiology, Pneumology...) > GCP Training, > Training in Regulatory Affairs (Submissions to CA, EC, CCTIRS, CNIL and CNOM, CTA, eCTD...), > Medical Training (Cardiology, Neurology/Psychiatry, Oncology, Endocrinology, Infectiology, Pneumology...)



Université Paris Cité

• France
• Higher Education
• 700 & Above Employee

• PHD Student

  • Oct 2011 - Sep 2014

  Grant from French Ministry of Research; Doctoral School: "Frontières du Vivant" > Cannabinoid pharmacology in neurons > In charge of a cell culture platform (stocks/orders, budget, user training to health and safety rules, material maintenance) > Supervision of interns (6) and of practical works > Publications (3) / Oral communications in France (2) and abroad (3) Publications: Ladarre D, Roland AB, Biedzinski S, Ricobaraza A, Lenkei Z (2015) Polarized cellular patterns of endocannabinoid production and detection shape cannabinoid signaling in neurons. Front Cell Neurosci. 8:426 Gaffuri AL, Ladarre D, Lenkei Z (2012) Type-1 Cannabinoid Receptor Signaling in Neuronal Development. Pharmacology 90: 19-39 Simon AC, Loverdo C, Gaffuri AL, Urbanski M, Ladarre D, Carrel D, Rivals I, Leterrier C, Benichou O, Dournaud P, Szabo B, Voituriez R, Lenkei Z (2013) Activation-dependent plasticity of polarized GPCR distribution on the neuronal surface. J Mol Cell Biol 5: 250-265



ESPCI Paris - PSL

• France
• Higher Education
• 100 - 200 Employee

• Ingénieur

  • 2006 - 2011



Complétude

• France
• Education Administration Programs
• 700 & Above Employee

• Tuition center management

  • 2005 - 2010

  In charge of a private tuition center (week-ends and holidays) Management of teachers' team (10-15 teachers), center organization, communication with Complétude and supervision of pupils (80-150 pupils from 11 to 18 years old) In charge of a private tuition center (week-ends and holidays) Management of teachers' team (10-15 teachers), center organization, communication with Complétude and supervision of pupils (80-150 pupils from 11 to 18 years old)