Associate Director of Project Management Country
il y a 1 jour
Directeur Associe, Project ManagementCountry Operations Reports to: Head of Country OperationsLocation: LevalloisPerret Resume du poste Le Directeur Associe, Project Management Country Operations (AD PMCO) est responsable, dans sa region, de lexecution reussie des livrables de letude et de la qualite de lexecution des procedures protocolaires hautement prioritaires et/ou complexes, en respectant les bonnes pratiques cliniques (GCP) et les exigences reglementaires en constante evolution, et en assurant la qualite et la coherence des activites de monitoring dans les delais impartis.LAD PMCO est responsable de la coordination des activites de demarrage rapide dans les pays assignes, en collaboration avec la CRO. LAD PMCO veillera egalement au respect des delais et a latteinte des etapes definit comme objectif pour letude, ainsi qua lidentification, la gestion et la communication des risques a lequipe de letude et a la preparation des plans dattenuation des risques. LAD PMCO veillera a ce que les activites de monitoring sur les sites de letude de lARC assignees par la CRO,quil soit dedie, FSP ou interne permettent didentifier et de resoudre efficacement les problmes. LAD PMCO travaillera avec la CRO pour reviser les plans nationaux et les echeanciers specifiques a letude.
Il/elle devra sassurer que la conception et les echeanciers de letude sont realisables dans lenvironnement local et repondent aux attentes en matire de performance. LAD PMCO veillera egalement a ce que les etudes assignees dans le pays soient dotees de ressources appropriees. LAD PMCO veillera egalement a ce que la CRO comprenne les processus et procedures complexes des protocoles et pourra soutenir la formation de lARC specifique aux protocoles. LAD PMCO coordonnera avec le Site Management Lead (SML) la participation aux visites de supervision du site (sur place ou a distance) en fonction des signaux de qualite observes dans les etudes assignees, avec la CRO, lARC dedie, lARC FSP ou lARC interne, selon le cas, ou avec le personnel de Global Medical Affairs pour les visites dengagement.
Principales responsabilites Qualite et respect des delais des livrables de letude (identification du site, faisabilite, demarrage, recrutement, livrables de donnees, archivage de la documentation complte de letude) pour la ou les etudes assignees.Rapport proactif des problmes specifiques a letude (y compris les indicateurs de monitoring de) a lequipe de letude via Study Lead Country Operations (SLCO). Qualite de la supervision du monitoring dans le pays pour les etudes assignees. Atteindre les objectifs de recrutement pour letude (les etudes) assignee(s).Livraison et negociation du CDA(sur la base des paramtres preapprouves et independamment de la partie executante).span style
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