Apprentice Clinical Operations

**Alternant(e) Recherche CliniqueReports to**: Associate Director Country Operations Line ManagerLocation: LevalloisPerret Principales Responsabilites Rattache(e) au departement des Operations Cliniques FranceBeLux, en collaboration avec lAssociate Directeur Country Operations, vous participerez aux : Mission CTA (Clinical Trial Assistant)Mise a jour et contrle qualite des TMFs pour les etudes cliniquesContribution a la constitution des dossiers de soumission aux comites dethique et aux autorites reglementairesAide a la realisation de la partie administrative dont la redaction de documents tels que CDA, CTA, etc. (sous la responsabilite du PMCO)Support des PMCO (Project Manager Country Operation) et SML (Site Management Lead)Aide a la revue des rapports de monitoring et des outils de suivi de la qualite de letudeAide a la collecte et a la revue des metricsAide au remplissage de trackersAide a la gestion des centres investigateurs en collaboration avec les SMLParticipation au contrle de la qualiteRevision et commentaires des proceduresSuivi et aide a lamelioration de lattribution et de la conformite des formationsVeille reglementaireCreation doutils pour optimiser le processus et le delai de soumission et de reponse aux autorites QUALIFICATIONSAutonomie (equipe en teletravail), sens de lorganisation et aptitude a travailler en equipe a distance, esprit de synthse.Bonnes aptitudes de communication, adaptabilite. PROFIL RECHERCHeFormation scientifique et/ou medicale BAC+5 minimum Connaissances scientifiques et medicales generales.Maitrise de la bureautique : Pack Office incluant Powerpoint Une experience, stage, deja realisee en entreprise ou a lhpital souhaiteeUn bon niveau danglais (interlocuteurs internationaux) Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of lifechanging medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat antiacetylcholine receptor (AchR) antibodypositive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD).

Alexion also has two highly innovative enzyme replacement therapies for patients with lifethreatening and ultrarare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LALD) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several midtolatestage therapies, including a copperbinding agent for Wilson disease, an antineonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)mediated diseases and an oral Factor D inhibitor as well as several earlystage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on hematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries.