Clinical Project Manager

il y a 3 jours


ÎledeFrance, France EXCELYA Temps plein

Créée en 2014, Excelya est une organisation de recherche sous contrat (CRO) « people centered ».


Nous proposons une expérience personnelle et authentique au sein d'une jeune entreprise de santé ambitieuse en passe de devenir le leader de la recherche clinique en Europe grâce à nos 800 Excelyates. Nous nous engageons à donner à chaque Excelyate les moyens d'exprimer ses talents naturels, de développer son plein potentiel et de s'investir dans notre projet unique.

Pour en savoir plus sur nous, visitez www.excelya.com


Activités :


Dans le cadre de cette mission, le prestataire peut être amené à assister les Attachés de Recherche Clinique, le data Manager, et le manager des affaires cliniques.


Gestion globale des essais cliniques

  • Documents de l’étude (protocole et rapports)
  • Gestion opérationnelle des études de la sélection à la clôture (donner une orientation aux équipes, contribuer aux procédures de sélection des patients, gestion du monitoring et des dispositifs, suivi des données cliniques et de sécurité)
  • Réunion et Compte-rendu du suivi de l’étude (données, monitoring, incidents, recommandations et solutions aux problèmes identifiés…)
  • Documentation de la qualité de l’étude


Gestion règlementaire des essais cliniques

  • Soumission règlementaire : obtention des autorisations des autorités compétentes et comités de protection des personnes
  • Préparation de documents spécifiques selon le pays et/ou les centres d’investigation clinique Tracking et Metrics (versions, approbations…)
  • Responsable du contenu du « Trial Master File »
  • Référent pour les audits/inspections menés sur les études cliniques supervisées Etablissement et suivi du budget des centres


Etablissement et suivi du budget des centres

  • Etablissement des contrats et suivi du budget
  • Procédure / Fichier Excel


Gestion des CRO / Partners

  • Formations, suivi et supervision des activités hebdomadaires / reporting
  • Gestion du budget


Profil recherché :


Les compétences attendues pour la réalisation des travaux sont de type « Chef de Projet clinique » avec un niveau « confirmé ».

Les critères qualitatifs d’évaluation des offres de services sont les suivants :

  • Excellentes capacités de planification, d'organisation et de résolution de problèmes
  • Excellentes compétences en communication verbale, écrite et en présentation en Anglais
  • Bonnes capacités d'analyse et de négociation, et de synthèse
  • Capacités de leadership
  • Etre rigoureux et proactif, et force de proposition
  • Connaissances approfondies en matière de recherche clinique et dispositifs médicaux : ISO 14155, réglementation européenne des DM 2017/745, FDA CFR Part 812 et Part 814
  • Efficacité à travailler de manière autonome au sein d'une équipe clinique.
  • Anglais courant
  • Formation scientifique ou qualité
  • Connaissance en cardiologie et chirurgie cardiaque, sera appréciée
  • Expérience dans une fonction de chef de projet d’au moins 4 ans

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