ICON plc

Senior Clinical Data Manager

ICON plc

full-time

Posted on:

Origin:  • 🇺🇸 United States • California

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Coordinates CDM process initiatives, including project management, process definition, implementation, change management, and training plans.
  • Provides regular communications to CDM staff on CDM Operation activities (e.g. process alerts, training updates, changes, and initiative announcements).
  • Supports the development and revision of CDM processes for both outsourced and in-house studies.
  • May act as a point of contact and support for CDM staff on key process topics related to data management activities during study startup, conduct, and close out, and working in CDM systems.
  • Collaborates with key stakeholders and CDM Operations to support CDM team on setup and management of EDC local lab activities.
  • Supports the maintenance of the CDM Subject Matter Expert (SME) network for process topics, facilitating timely updates and discussions.
  • Supports the maintenance and enhancements of departmental Sharepoint sites and trackers, as needed.
  • Assists in determining role assignment for the Learning Management System (LMS) and associated learning plans.
  • Supports CDM staff with Quality Assurance related activities such as inspection & audit responses, in collaboration with the CDM Operations Compliance & Quality team.

Requirements

  • Preferred 6 plus years or equivalent experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
  • Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
  • Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
  • Knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management; clinical experience in one or more of the following therapeutic areas desired: cell therapy, oncology, GI, Neuroscience, PDT, Rare disease, Vaccines and/or vaccine.
  • Preferred experience with FDA, EMA or other regulatory inspections of sponsor or CROs
  • Ability to handle multiple projects simultaneously.
  • Strong knowledge of data management best practices & technologies as applied to clinical trials.
  • Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.
  • Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
  • Au moins six ans d'expérience, ou équivalent, en gestion de données et/ou en processus de développement de médicaments, avec une expertise des interfaces transversales avec la fonction de gestion des données.
  • Excellente compréhension des documents d'essais cliniques (protocoles, plans d'analyse statistique, CRF, rapports d'étude) et des processus.
  • Excellentes compétences avérées en gestion de projet et expérience de la gestion des activités de gestion des données pour de grands programmes de développement de médicaments.
  • Connaissance des BPC, des directives réglementaires et de l'ICH applicables à la gestion des données cliniques ;Expérience clinique souhaitée dans un ou plusieurs des domaines thérapeutiques suivants : thérapie cellulaire, oncologie, gastro-entéologie, neurosciences, PDT, maladies rares, vaccins.
  • Expérience souhaitée avec la FDA, l'EMA ou d'autres inspections réglementaires de promoteurs ou de CRO.
  • Capacité à gérer plusieurs projets simultanément.
  • Excellente connaissance des meilleures pratiques et technologies de gestion des données appliquées aux essais cliniques.
  • Connaissance approfondie du processus global de développement de médicaments, avec une expertise des interfaces transversales avec la fonction de gestion des données.
  • Connaissance approfondie des réglementations FDA et ICH et des normes industrielles applicables au processus de saisie et de gestion des données.