Clinical Data Manager jobs in United States

As a Sr. Clinical Data Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• 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 stud-
ies.
• May act as a point of contact and support for CDM staff on key process topics related to data
man- agement 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 man-
agement of EDC local lab activities.
• Supports the maintenance of the CDM Subject Matter Expert (SME) network for process topics, fa-
cilitating 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.

•Coordonne les initiatives du processus CDM, notamment la gestion de projet, la définition des processus, la mise en œuvre, la gestion du changement et les plans de formation.
• Assure une communication régulière avec le personnel CDM sur les activités opérationnelles CDM (par exemple, alertes processus, mises à jour de formation, changements et annonces d'initiatives).
• Soutient le développement et la révision des processus CDM pour les études externalisées et internes.
• Peut servir de point de contact et de soutien au personnel CDM sur les aspects clés des processus liés aux activités de gestion des données pendant le démarrage, la conduite et la clôture des études, ainsi que sur l'utilisation des systèmes CDM.
• Collabore avec les principales parties prenantes et le service Opérations CDM pour soutenir l'équipe CDM dans la mise en place et la gestion des activités des laboratoires locaux d'EDC.
• Soutient la maintenance du réseau d'experts en la matière CDM pour les sujets de processus, facilitant ainsi les mises à jour et les discussions en temps opportun.
• Soutient la maintenance et l'amélioration des sites SharePoint et des outils de suivi du service, selon les besoins.
• Participer à la définition des rôles pour le système de gestion de l'apprentissage (LMS) et les plans de formation associés.
• Assister le personnel du CDM dans les activités liées à l'assurance qualité, telles que les inspections et les audits, en collaboration avec l'équipe Conformité et Qualité des opérations du CDM.

You are:

• Preferred 6 plus years or equivalent experience in data management and/or drug development pro-
cess with expertise in the cross-functional interfaces with the data management function.
• Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs,
study re- ports) 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, Neu- roscience, 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
inter- faces 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-entérologie, 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.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.