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ICON plc is a world-leading healthcare intelligence and clinical research organization. Supports the Clinical Study Manager in the oversight of Country and Site Trial Master Files (TMF.
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Minimum 2 years clinical site monitoring experience from CRO or Pharmaceutical company. Contribute to the identification of new sites for clinical trials. Were 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.
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Des connaissances et une comprhension approfondies des bonnes pratiques cliniques labores par la Confrence internationale sur lharmonisation (BPC-CIH) Exprience dans la surveillance centralise/axe sur les risques/cible (prfrable.
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Mettre en place la structure complte de gestion des centres dtude, entre autres, les visites de surveillance, les valuations rglementaires, la gestion de lapprovisionnement en mdicaments, pour assurer la conformit au protocole, aux BPC, aux rglementations mondiales et locales, et aux processus mondiaux et locaux.
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Soutenir le travail du gestionnaire de ltude clinique pour la surveillance des fichiers matres de ltude (FME) aux centres dtude et lchelle du pays. Baccalaurat ou diplme suprieur en sciences de la vie ou un quivalent.
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To ensure compliance with protocol, GCP, global and local regulations, global and local processes. During all phases of the trial ensure archiving per relevant SOP. Assume ambassadorial role to facilitate communication between sites and sponsor CPO to increase value proposition to investigators.
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Comprehensive knowledge and understanding of ICH-GCP. ICON, y compris ses filiales, est un employeur inclusif qui offre des chances gales et sengage offrir un cadre de travail exempt de discrimination et de harclement.
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Provide feedback on site performance for future trial site feasibility/selection. Fournir des commentaires sur les performances des centres dtude afin dvaluer leur candidature pour de futures tudes cliniques.
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Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
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Examiner et grer continuellement les donnes recueillies aux centres dtude, afin de rsoudre rapidement les problmes techniques et de contenu pour atteindre les cibles de verrouillage de la base de donnes en temps opportun.
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Experience/working knowledge of the oncology disease area (preferred but not required) Tous et toutes les candidat(e)s qualifi(e)s bnficieront dune considration gale pour lemploi, sans distinction par rapport la race, la couleur, la religion, le sexe, lorientation sexuelle, lidentit de genre, lorigine nationale, le handicap ou le statut dancien combattant protg.
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At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.
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Si, en raison dun problme de sant ou dun handicap, vous avez besoin damnagements adapts et raisonnables pour toute partie du processus de candidature, ou pour excuter les fonctions essentielles dun poste, veuillez nous en informer au moyen du formulaire ci-dessous.
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Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. Able and willing to travel up to 60% regionally (sites in Quebec City and Montreal.
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Effectuer la rdaction complte et la distribution des rapports sur les visites de surveillance, conformment aux procdures dexploitation normalises pertinentes. Minimum de 2 4 ans dexprience en surveillance de centres dtude pour une entreprise de recherche contractuelle ou une socit pharmaceutique.
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Title: clinical research associate Company: Icon Clinical Research
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