Julie GATEL
Responsable des Opérations Cliniques at MEDICAL INITIATIVES- Claim this Profile
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Français Native or bilingual proficiency
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Anglais Full professional proficiency
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Bio
Armelle VERRY
Julie has been instrumental in the conduct of Human Factors studies in Europe and USA during her stay at BD. She managed heavy workload and developed relationships with other BD colleagues and 3rd party vendors that have been very beneficial for study conduct. She has demonstrated strong skills to manage Human Factors studies from preparation to analysis and report and also to resolve any issues to ensure objectives were met. I really enjoyed working with her hand in hand as study manager in the clinical development team of BD Medical Affairs. Julie is a person we can definitly rely on and a very professional Clinical Project Manager.
Jean-Marie Préaud
I have been working with Julie from 2007 to 2014 on the Meningitis Vaccine Project. Julie was Clinical Operations Manager while I was Pharmaceutical Operations Officer, meaning that we were working in close collaboration to coordinate and carry out the pharmaceutical and clinical operations along with the MVP project in a smooth and efficient way. Julie is a very well organized person, showing professionnel behaviour and timelines oriented. She was bringing constant attention to her colleagues ; her management style is participative then good in decision-making; she is able to motivate her team even in difficult situation and I really appreciate her commitment at every step of the project. She was definitely instrumental to the success of the MVP clinical operations. In addition, Julie is a very pleasant to work with, and I would recommend her clinical background, management skills and team spirit to manage a clinical team if there is a job opportunity.
Armelle VERRY
Julie has been instrumental in the conduct of Human Factors studies in Europe and USA during her stay at BD. She managed heavy workload and developed relationships with other BD colleagues and 3rd party vendors that have been very beneficial for study conduct. She has demonstrated strong skills to manage Human Factors studies from preparation to analysis and report and also to resolve any issues to ensure objectives were met. I really enjoyed working with her hand in hand as study manager in the clinical development team of BD Medical Affairs. Julie is a person we can definitly rely on and a very professional Clinical Project Manager.
Jean-Marie Préaud
I have been working with Julie from 2007 to 2014 on the Meningitis Vaccine Project. Julie was Clinical Operations Manager while I was Pharmaceutical Operations Officer, meaning that we were working in close collaboration to coordinate and carry out the pharmaceutical and clinical operations along with the MVP project in a smooth and efficient way. Julie is a very well organized person, showing professionnel behaviour and timelines oriented. She was bringing constant attention to her colleagues ; her management style is participative then good in decision-making; she is able to motivate her team even in difficult situation and I really appreciate her commitment at every step of the project. She was definitely instrumental to the success of the MVP clinical operations. In addition, Julie is a very pleasant to work with, and I would recommend her clinical background, management skills and team spirit to manage a clinical team if there is a job opportunity.
Armelle VERRY
Julie has been instrumental in the conduct of Human Factors studies in Europe and USA during her stay at BD. She managed heavy workload and developed relationships with other BD colleagues and 3rd party vendors that have been very beneficial for study conduct. She has demonstrated strong skills to manage Human Factors studies from preparation to analysis and report and also to resolve any issues to ensure objectives were met. I really enjoyed working with her hand in hand as study manager in the clinical development team of BD Medical Affairs. Julie is a person we can definitly rely on and a very professional Clinical Project Manager.
Jean-Marie Préaud
I have been working with Julie from 2007 to 2014 on the Meningitis Vaccine Project. Julie was Clinical Operations Manager while I was Pharmaceutical Operations Officer, meaning that we were working in close collaboration to coordinate and carry out the pharmaceutical and clinical operations along with the MVP project in a smooth and efficient way. Julie is a very well organized person, showing professionnel behaviour and timelines oriented. She was bringing constant attention to her colleagues ; her management style is participative then good in decision-making; she is able to motivate her team even in difficult situation and I really appreciate her commitment at every step of the project. She was definitely instrumental to the success of the MVP clinical operations. In addition, Julie is a very pleasant to work with, and I would recommend her clinical background, management skills and team spirit to manage a clinical team if there is a job opportunity.
Armelle VERRY
Julie has been instrumental in the conduct of Human Factors studies in Europe and USA during her stay at BD. She managed heavy workload and developed relationships with other BD colleagues and 3rd party vendors that have been very beneficial for study conduct. She has demonstrated strong skills to manage Human Factors studies from preparation to analysis and report and also to resolve any issues to ensure objectives were met. I really enjoyed working with her hand in hand as study manager in the clinical development team of BD Medical Affairs. Julie is a person we can definitly rely on and a very professional Clinical Project Manager.
Jean-Marie Préaud
I have been working with Julie from 2007 to 2014 on the Meningitis Vaccine Project. Julie was Clinical Operations Manager while I was Pharmaceutical Operations Officer, meaning that we were working in close collaboration to coordinate and carry out the pharmaceutical and clinical operations along with the MVP project in a smooth and efficient way. Julie is a very well organized person, showing professionnel behaviour and timelines oriented. She was bringing constant attention to her colleagues ; her management style is participative then good in decision-making; she is able to motivate her team even in difficult situation and I really appreciate her commitment at every step of the project. She was definitely instrumental to the success of the MVP clinical operations. In addition, Julie is a very pleasant to work with, and I would recommend her clinical background, management skills and team spirit to manage a clinical team if there is a job opportunity.
Experience
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MEDICAL INITIATIVES
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France
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Research
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1 - 100 Employee
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Responsable des Opérations Cliniques
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May 2021 - Present
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Chargée d'étude
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Mar 2018 - May 2021
Mise en place et coordination de l'activité recherche dans le service d'ORL (HEH); montage de projets, écriture de protocole,consentement, CRF. Support aux équipes pour le montage de dossiers réglementaires en lien avec la DRCI. Mise en place d'outils pour promouvoir la recherche dans le service. Support pour des études COVID 19 menées aux HCL pour le COVID; montage d'étude en urgence et saisie de données. Mise en place et coordination de l'activité recherche dans le service d'ORL (HEH); montage de projets, écriture de protocole,consentement, CRF. Support aux équipes pour le montage de dossiers réglementaires en lien avec la DRCI. Mise en place d'outils pour promouvoir la recherche dans le service. Support pour des études COVID 19 menées aux HCL pour le COVID; montage d'étude en urgence et saisie de données.
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Becton Dickinson
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Hospitals and Health Care
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1 - 100 Employee
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Chef de Projet/Human Factor Study Manager
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Oct 2016 - Dec 2017
Supervision de la conduite des études Human Factor (planification, rédaction des documents d'études, organisation du circuit de sélection du/des sous-traitant(s), interaction avec le core team(R&D, Marketing, Affaires réglementaire.s..) pour l'élaboration du design des études, suivi d'étude, récolte des données, suivi des analyses et des rapports d'études...). Supervision de la conduite des études Human Factor (planification, rédaction des documents d'études, organisation du circuit de sélection du/des sous-traitant(s), interaction avec le core team(R&D, Marketing, Affaires réglementaire.s..) pour l'élaboration du design des études, suivi d'étude, récolte des données, suivi des analyses et des rapports d'études...).
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PATH (ONG)
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United States
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Medical Practices
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Coordinatrice d'études cliniques/ Manager
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May 2007 - Dec 2014
Coordinatrice et Manager des Opérations Cliniques dans une ONG (PATH) à Ferney-Voltaire- Projet Vaccin Méningite (MVP), partenariat entre l’OMS et PATH- http://www.meningvax.org/ Vaccin (Phase II, III) Afrique de l’Ouest et Inde Lors de ces 7 années chez PATH, j'ai supervisé des études cliniques (principalement conduites en Afrique de l'Ouest: Mali, Ghana, Sénégal et Gambie) en travaillant étroitement avec des CROs locales et indiennes, des experts internationaux, des sites peu ou pas expérimentés (et qui le sont devenus) et des organisations internationales). Supervision de l’équipe clinique - Mise en place et gestion de plan clinique - supervision des activités cliniques (documents essentiels, aspects réglementaires et éthiques, rédaction et mise à jour de SOPs, rapport clinique, suivi d’audit) - Coordination des partenaires cliniques (CROs, audit, medical writers, laboratoires d’analyse, investigateurs)- Formation d'ARCs et investigateurs (BPCs et spécificités des études) - Participation à l’interprétation des données. Show less
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Ipsen
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France
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Pharmaceutical Manufacturing
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700 & Above Employee
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Coordinatrice/ARC Senior
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Dec 2005 - May 2007
Domaine thérapeutique: cancer du sein et de la prostate, endocrinologie - Phase I à III en Europe Domaine thérapeutique: cancer du sein et de la prostate, endocrinologie - Phase I à III en Europe
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PPD
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United States
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Research Services
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700 & Above Employee
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ARC
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Sep 2005 - Dec 2005
Paludisme- étude observationnelle en pédiatrie au Mali (suivi de 2 sites ruraux) Paludisme- étude observationnelle en pédiatrie au Mali (suivi de 2 sites ruraux)
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Chiesi Group
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Italy
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Pharmaceutical Manufacturing
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700 & Above Employee
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ARC Coordinatrice
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May 2005 - Jul 2005
Domaine thérapeutique:dermatologie-Phase IIIb – Europe Domaine thérapeutique:dermatologie-Phase IIIb – Europe
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Quintiles
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Spain
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ARC
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Feb 2003 - Nov 2004
Domaine thérapeutique: cardiologie, neurologie, psychatrie, gastro-entérologie et endocrinologie- Phase II et IV- Europe Domaine thérapeutique: cardiologie, neurologie, psychatrie, gastro-entérologie et endocrinologie- Phase II et IV- Europe
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Education
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2014 - 2014
Fondation Mérieux, Annecy, France
Advanced Vaccinology Course (8th ADVAC), -
2013 -
PATH, Ferney-Voltaire, France
Pro-Project Manager Training -
2010 -
Université Victor Segalen (Bordeaux II)
DU, Vaccinologie -
2003 -
Sup Santé, Paris, France
Attachée de Recherche Clinique/Clinical Research Associate -
2000 -
Université Henri Poincaré (Nancy I)
DESS, Informatique double compétence -
1999 -
Université de Rennes I
Maîtrise, Biologie moléculaire, physiologie -
1998 -
Université de Rennes I
Licence, Biochimie
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