Clinical trial document manager F/H
il y a 3 semaines
Description de la mission
En tant que Clinical trial document manager, vous serez responsable de la supervision de tous les dossiers de niveau étude du Trial Master File (TMF), y compris la mise en place, le contrôle qualité périodique et final, ainsi que le transfert et l'archivage final. Vous développerez des SOPs de supervision et d'archivage du TMF et gérerez la plateforme d'archivage du TMF.
A ce titre, vos principales missions seront de :
Développer et mettre en œuvre une stratégie complète de gestion des dossiers, incluant la supervision et les SOPs d'archivage ainsi que la mise en place et la gestion d'une plateforme d'archivage du TMF. Sélectionner et intégrer/mettre en œuvre une plateforme d'archivage TMF. Superviser le processus d'archivage du TMF, en veillant à ce que tous les documents soient correctement classés, indexés et accessibles. Assurer l'état de préparation pour les inspections des TMF externalisés en effectuant des contrôles qualité périodiques et en assurant un suivi pour garantir la résolution rapide et appropriée des constats. Préparer et soutenir les inspections des autorités de santé (contrôles qualité du TMF, extraction de documents pendant les inspections). Se tenir à jour des exigences réglementaires et des meilleures pratiques de l'industrie en matière de gestion des dossiers et du TMF. Chez Orano, nous valorisons la diversité et croyons en l'égalité des chances. Rejoignez-nous dès maintenant et laissez votre empreinte dans cette aventure passionnante.-
Clinical Trial Manager
Il y a 2 mois
Paris, France TSP (A Syneos Health Company) Temps pleinLocation: Paris, IDF, France Date Updated: Oct 10, 2024 Job ID: 6159 **Description** **ABOUT QYNAPSE** Headquartered in France, in the United States and in Canada, the Qynapse neuroscience team, is dedicated to building tools and software that analyze brain images and related markers to identify and track neurodegeneration and neuroinflammation across CNS...
-
Clinical Trial Manager
Il y a 2 mois
Paris, France ICON Temps pleinWe are constantly looking for motivated, reliable and dedicated **CTMs who can demonstrate a first similar experience as a Clinical Trial Manager, Local Trial Manager or Study Manager within the pharmaceutical industry or a CRO.** **As a Clinical Trial Manager** you will be dedicated to one of our global pharmaceutical clients; with whom ICON shares a...
-
Clinical Trial Manager
Il y a 6 mois
Paris, France Amgen Temps pleinPatients. For them, we research, develop and manufacture innovative therapies for serious diseases, using living resources. This approach is based on cutting-edge technologies, such as human genetics, which enable us to characterise the molecular mechanisms at the root of diseases. Amgen focuses its research on diseases for which there is still a significant...
-
Senior Clinical Trials Manager
il y a 1 mois
Paris, Île-de-France Allucent Temps pleinRole OverviewWe are looking for a highly skilled and experienced Sr. Clinical Research Associate to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for monitoring and managing clinical trials to ensure compliance with regulatory requirements and study protocols.Key ResponsibilitiesProvide functional...
-
Clinical Trial Assistant
Il y a 6 mois
Paris, France ICON Temps pleinWe are constantly looking for motivated, reliable and dedicated **CTAs who can demonstrate a first experience as a Clinical Trial Assistant or In-house CRA within the pharmaceutical industry or a CRO**.** **As a Clinical Trial Assistant** you will be dedicated to one of our global pharmaceutical clients; with whom ICON shares a culture of innovation,...
-
Clinical Trial Assistant
Il y a 2 mois
Paris, France Icon plc Temps pleinCTA - France ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are constantly looking for motivated, reliable and dedicated CTAs who can...
-
Clinical Trial Assistant
Il y a 6 mois
Paris, France Nanobiotix Temps pleinWe are looking for a self-started Clinical Trial Assistant to lay the foundation for game-changing nanomedicine research to help millions of patients around the globe. Since our inception, our team has been committed to researching and developing disruptive nanomedicine approaches that could revolutionise the way many cancers are treated. Nanobiotix designs...
-
Clinical Trial Assistant
il y a 2 semaines
Paris, France KCR Temps plein**We see human behind every number** **Clinical Trial Assistant** **Location: Issy Les Moulineaux, Paris, France (hybrid - 2 days in the office)** On behalf of our partner, one of the global leaders in clinical research, we are seeking an experienced, motivated, reliable and dedicated **CTAs who can demonstrate a first experience as a Clinical Trial...
-
Clinical Trials Assistant
il y a 4 semaines
Paris, Île-de-France IQVIA Temps pleinThe IQVIA Research and Development Solutions team drives innovation in the life sciences industry by helping our healthcare customers find effective treatments for patients. As a Clinical Research Administrative Assistant, you will provide administrative support to our clinical teams, contributing to the research and development of new treatments.Key...
-
Local Clinical Trial Assistant
Il y a 6 mois
Paris, France Excelya Temps pleinCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service,...
-
Clinical Trial Assistant
Il y a 6 mois
Paris, France ICON Temps pleinAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
-
Clinical Trial Assistant
Il y a 2 mois
Paris, France Pharmacos Temps plein**PROFIL**: - BTS / Master en sciences - 1 à 2 ans d'expérience en opérations cliniques, dans un labo ou dans une CRO - Très bonne connaissance du Pack Office - Anglais technique **ROLES ET RESPONSABILITES**: - Assister dans l'organisation logistique des réunions de lancement et de suivi des essais cliniques, y compris la préparation des classeurs...
-
Clinical Trial Assistant Late Development
Il y a 6 mois
Paris, France ICON plc Temps pleinWe are constantly looking for motivated, reliable and dedicated **CTAs who can demonstrate a first experience as a Clinical Trial Assistant or In-house CRA within the pharmaceutical industry or a CRO**.** **As a Clinical Trial Assistant** you will be dedicated to one of our global pharmaceutical clients; with whom ICON shares a culture of innovation,...
-
Clinical Trial Assistant
Il y a 6 mois
Paris 13e, France ICM Institut du Cerveau Temps plein_**Clinical Trial Assistant (M/F)**_ - **Position to be filled as soon as possible**_ - **CDI **_ - **Based in Paris 13**_ - The Paris Brain Institute is a private foundation recognized as being of public utility, whose purpose is fundamental and clinical research on the nervous system. On the same site, 700 researchers, engineers and doctors cover all the...
-
Clinical Research Specialist
il y a 3 jours
Paris, Île-de-France Excelya Temps pleinWe are Excelya, a young and ambitious health company on the path to becoming the clinical research leader in Europe. With over 900 team members, we offer a personal and authentic experience that encourages growth and development.Our ApproachOur unique one-stop provider service model allows our team members to evolve through diverse projects, collaborating...
-
Global Clinical Trial Assistant
Il y a 2 mois
Paris, France Pharmacos Temps plein**ROLES ET RESPONSABILITES**: - Assister dans l'organisation logistique des réunions de lancement et de suivi des essais cliniques, y compris la préparation des classeurs investigateurs, la gestion du stock de matériel d'étude, et le suivi du transport des échantillons - Maintenir et archiver les documents relatifs aux essais cliniques, en conformité...
-
Clinical Trials Assistant
Il y a 6 mois
Paris, France IQVIA Temps pleinThe IQVIA Research and Development Solutions team is focused on helping our healthcare customers to find innovative treatments solutions for patients with the common, large or rarest illnesses. Providing administrative support to the clinical teams members could make your contribution to the research. We seek dynamic and motivated people who truly want to...
-
Clinical Trial Assistant
Il y a 3 mois
Paris, France Institut du cerveau Temps pleinPrise de poste : 01/10/2024 BAC +3/+4 Paris Nombre de poste : 1 CDI De 40k à 50k euros **Description du poste et des missions**: **Position to be filled as soon as possible | Permanent position** - The Paris Brain Institute is a private foundation recognized as being of public utility, whose purpose is fundamental and clinical research on the nervous...
-
Clinical Trial Assistant
il y a 4 semaines
Paris, France Pharmacos Temps plein**ROLES ET RESPONSABILITES**: - Assister dans l'organisation logistique des réunions de lancement et de suivi des essais cliniques, y compris la préparation des classeurs investigateurs, la gestion du stock de matériel d'étude, et le suivi du transport des échantillons - Maintenir et archiver les documents relatifs aux essais cliniques, en conformité...
-
Clinical Trial Assistant
Il y a 6 mois
Paris, France Institut du cerveau Temps pleinPrise de poste non définie BAC +3/+4 Paris Nombre de postes non défini CDI Rémunération non définie **Description du poste et des missions**: - The Paris Brain Institute is a private foundation recognized as being of public utility, whose purpose is fundamental and clinical research on the nervous system. On the same site, 700 researchers, engineers...