DESCRIPTION :
* Coordinate the scientific work with all collaborators involved in the task led by Inserm.
* Assess existing designs concerning artificial intelligence (AI) based Digital Medical Devices (DMDs) and interoperable devices.
* Analyze, based on the clinical evidence and clinical studies (as clinical trials or real-world data - RWD - analysis), the DMDs that got reimbursement agreement from the French Health Technology Assessment (HTA) body HAS ("Haute Autorité de Santé") and those that did not.
* Identify the needs concerning DMD designs that did not meet the "evidence threshold" and HAS requirements, i.e., published methodological guidelines by HAS.
* Study existing requirements for DMDs in various European Union (EU) Member States (e.g., France, Germany, Belgium).
* Develop a framework and guidelines of trial or study designs that could be used to evaluate DMDs according to each subtype, i.e., therapeutics, diagnostics, monitoring, disease management using either hardware with software or software alone, in EU.
* Collaborate with HAS to cross-validate findings.
Principales activités
* Evaluate the methodological needs in innovative designs for accelerating access of innovation to patients.
* Conduct literature reviews on DMD clinical evaluation and reimbursement frameworks.
* Design and implement methodologies for evaluating DMDs.
* Write scientific articles and present findings at conferences.
* Organize regular meetings with project collaborators.
Code d'emploi : Responsable Recherche Clinique (h/f)
Domaine professionnel actuel : Chercheurs et Analystes
Niveau de formation : Bac+5
Temps partiel / Temps plein : Plein temps
Type de contrat : Contrat à durée indéterminée (CDI)
Compétences : Python (Langage de Programmation), Programming Languages, Anglais, Français, Sens de l'Organisation, Esprit d'Équipe, Motivation Personnelle, Biostatistique, Travaux Cliniques, Évaluations Cliniques, Epidémiologie, Recherche Clinique, Santé Publique, Organisation d'Événements, Economie de la Santé, Médecine, Approche Pluridisciplinaire, Documentation Scientifique, Recherche Scientifique, Etudes et Statistiques, Évaluation des Technologies, Gestion des Maladies, Matériel Médical, Revues Littéraires, Réalisation de Diagnostiques
Courriel :
sandrine.boulet@inria.fr
Téléphone :
0139635511
Type d'annonceur : Employeur direct