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GCP Archivist

GCP Archivist

IQVIA HoldingsEast Hanover, NJ, US
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Clinical Document Management Archivist

Location : Office based in East Hanover, NJ

Job Purpose

  • Responsible for delivery of archiving services for electronic and paper clinical trial related records in compliance with appropriate regulations and to meet the business needs
  • Drives implementation of CDGM initiatives, projects and process improvement activities to enhance clinical document management systems, processes and standards

Essential Functions

  • Act as Archivist, responsible for the management of archived records across multiple platforms. Collaborate closely with business and technical stakeholders to ensure records are maintained in compliance with regulatory standards and internal policies.
  • Act as Archivist for physical records collections managed in local onsite CDGM archives and offsite storage.
  • Ensure the archiving service for paper and electronic records is delivered in compliance with appropriate regulations and Sponsor's policies, and per agreed SLAs to meet business needs.
  • Act as Archiving subject matter experts supporting CDGM, business driven projects and activities relating to archive systems, processes and archived records.
  • Provides audit / inspection readiness support in relation to archiving, contributes to root cause analysis, identification and creation / delivery of CAPAs.
  • Serves as Subject Matter Expert on archiving training materials, formal and informal processes and tracking tools for electronic and physical clinical records.
  • Executes vendor oversight plans, in relation to archive staff and other third parties, monitors service metrics and identifies opportunities for improvement to the operating model. Acts as point of escalation for issues.
  • Identify and implement improvements to archive operations and services.
  • May act as business lead for innovation projects to enhance archive services.

    • Ideal Background

  • Bachelor's degree or equivalent and relevant industry experience.
  • Minimum of 3 / 4 years working in clinical research and development in the pharmaceutical industry (and / or Contract Research Organizations) with specific experience in clinical documentation and / or records & information management.
  • Strong influencing and presentation skills. Ability to communicate effectively at all levels.
  • High organizational awareness, including experience working in multi-disciplinary teams, across cultures and geographies.
  • Good negotiation, problem solving and conflict resolution skills; experience establishing trusted relationships with internal and external stakeholders.

    • IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

    IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

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    Archivist • East Hanover, NJ, US

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