Isabelle GIRAUD

Experience

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  Laboratoires Polivé-Tricosteril (J&J)

  Feb 1987 - Jun 1990

  Deputy Qualified Person

  - Regulatory Affairs: MAA dossiers, GMP and quality procedures for sterilized products- Liaised between the Manufacturing site and Headquarter for the coordination between R&D and Marketing departments- Quality Control of finished products and prepared the health authorities inspection dossier

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  PAREXEL International

  Jun 1990 - Jun 1999

  Line manager,Quality Assurance Manager and Project manager

  Contributed actively to company growth from 4 to 120 employees in 9 years and established harmonization between European affiliates and Corporate objectives. Developed and implemented alternative solutions to organizational issues about study timelines, planning, resources, project budgets.- Quality Assurance Manager: Ensured high quality work according to guidelines: ICH, GCP...- European Training Manager: Established training tools and maintained training programs - Regulatory Affairs Officer and Auditor: set-up and harmonization of SOPs, audits of phase III - International Project Manager: coordinated and liaised between sponsors, CRAs, investigators, hospital staff, central laboratory and authorities. Follow-up of 5 clinical trials Phase III- Line Manager: Supervised a 30 CRA's team in all clinical trial steps and trained 100± CRAs - CRA on Phases II, III, IV Clinical studies from set up to close-out visits Show less

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  3M

  Jul 2000 - Oct 2000

  European Clinical Trial Coordinator 3M Sante

  Set-up phase III in dermatology (6 European countries), large investigators’ meeting, CRA training, CRF design and printing, central laboratory, drug shipment

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  • 6 fixed-term contracts Norgine Pharma, Chiesi, Ethicon (J&J) ,Cornéal -Issy-les-Moulineaux

  Jan 2001 - Jan 2004

  Regulatory Affairs Officer

  - Norgine Pharma - Paris - Rx and OTC products - MAA dossier, France and Export. - Interfaced to requests from French Regulatory Authorities and advised marketing department - Chiesi - Courbevoie - Rx and OTC products - National registration procedure of Rx and OTC products- Ethicon (J&J) -Issy-les-Moulineaux - Medical Devices France and Export.- European Certification marking of medical devices. French translation of English medical devices labeling & information use - Cornéal - Paris- Medical Devices : - European Certification marking of Medical Devices Show less

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  GSK

  Jul 2001 - Dec 2001

  Regulatory Affairs Officer

  European registration of HIV products, Centralised and Mutual Recognition Procedures

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  Laboratoires Bailleul

  Sept 2004 - Aug 2006

  Deputy Qualified Person

  - Coordinated between Marketing, Medical, Regulatory departments and Manufacturing site- Implemented new French quality code of conduct and trained sales representatives- Managed a product storage site and initiated communication tools with the head office

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  Sanofi

  May 2007 - Oct 2007

  Logistic and Regulatory Coordinator Sanofi-aventis

  Logistic and Regulatory Coordinator in Global Medical Affairs-Clinical Operations-GMA-CO - Set-up of one clinical trial (12 countries) : coordination of drug supply packaging between the manufacturing site and the clinical trial teams in worldwide affiliates including local regulatory issues- Provided Supply Chain Managers with tight deadlines for packaging and distribution- Coordinated label jobs and Quality Control with internal and external packaging label provider

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  CEGEDIM

  Sept 2008 - Jun 2010

  National and International Project Manager Cegedim Strategic Data

  - Contributed to the set-up of new Medical Research department France: responsible for recruitment, developing and training of new associates (clinical research and regulatory affairs)- Supervised 5 direct reports and coordinated internal / external involved people in the affiliates- Project Management: Set-up and follow-up of a clinical trial Phase IV in Cardiology: 7000 patients, 700 physicians, 11 countries, and an epidemiological study in Diabetes: 4000 patients, 2000 physicians, 1 country Show less

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  Novartis Consumer Health

  Feb 2012 - Oct 2012

  Operations Supply Manager

  - Liaised globally with Supply Chain Managers between Supply Planning & Labeling, Quality Assurance, Operation Planning regarding clinical supply packaging order and study specific information- Coordinated label jobs with Drug Supply Management India and external label packaging providers- Coordinated all packaging steps with Operations globally and with Quality Assurance- Provided Supply Chain Managers with milestone dates of packaging and distribution

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  Inserm

  Jan 2014 - Jan 2015

  Clinical Project Manager

  - Project Manager in the COMBACTE (Combatting Bacterial Resistance in Europe) project which is one of the projects that is part of the "New Drugs For Bad Bugs" (ND4BB) programme. It is the result of the initial association between industry and two academic consortia, coordination along with representatives of the EFPIA,GlaxoSmithKline and Astra Zeneca. - ECRIN (European Clinical Research Infrastructures Network) coordinated by INSERM, is an infrastructure whose purpose is to facilitate the setting up of international trials in Europe. ECRIN is responsible for the management of the project's clinical trials through its European partners, ensuring coordination between the various national networks.- LScientific and administrative managment of the project work package including the production of deliverables and reports- Responsible for the communication with the other partners in the project- Participation in the project meetings as ECRIN representative- Liaised globallyCoordination of clinical trial operations and management performed by ECRIN-ERIC operation manager and ECRIN partners- Participation in the investigation selection process and cost evaluation- Participation with the ECRIN-ERIC manager in the quality assurance development and in the QA assessments to be performed by the sponsor Show less

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  Hôpital Necker-Enfants Malades

  Jan 2015 - Jan 2016

  National Healthcare Network Project Manager FIMARAD

  The healthcare network is a project launched as a part of National Plan for Rare Diseases by the French Ministry of Health. The project manager has to coordinate and animate the network to better serve the patients and contribute to improving the multidisciplinary cares provided to the patients in respect of their needs and expectations regarding their rare disease. - Contribution to the development of the web site.- Set-up a National Annual Day to introduce the healthcare network FIMARAD (70 people) in Paris.- Collaboration with many associations of patients based on very constructive work of systematic pinpointing what needs to improve in Rare Diseases network Show less

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  CERC

  Apr 2017 - Apr 2018

  Clinical Research Project Manager

  - Mission : Management of the clinical projects- Responsibilities : Design and coordination of clinical studies in accordance with applicable regulations, client's needs and requirements, quality, costs and timelines defined by contract and applicable procedures

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  COLLEGE NATIONAL DES GENERALISTES ENSEIGNANTS - COLLEGE ACADEMIQUE

  Dec 2020 - Jun 2022

  Clinical Project Manager

  The Coverage France outpatient therapeutic trial, supported by the CNGE, aims to assess the safety and efficacy of treatments taken in the early phase, in patients with COVID 19 and with risk factors for severe forms

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  AP-HP, Assistance Publique - Hôpitaux de Paris

  Sept 2022 - now

  Clinical Research Project Manager and Coordinator

  - Scientific, logistical and administrative management of the University Hospital Research program PrediMAP- Coordination of project governance bodies- Communication between the members of the consortium (academic and industrial partners) and the different actors of the project-Management of financial aspects (PIA / ANR)