Job Overview

Accountable for delivering user support related to clinical document management processes, adoption of TMF and good documentation practices across the business.

Drives implementation of CDGM initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards at Novartis.

Essential Functions

Support the development and delivery of fit for purpose end user support in relation to CDGM / TMF processes to Novartis business groups.

Partner with stakeholders across the business to understand user needs and root causes of issues in relation to TMF and CDGM service delivery and proactively identify/implement improvements to end user support activities.

Support for management of metrics/KPIs and dashboards relating to CDGM end user support and conduct data analysis to identify trends and issues.

Serves as Subject Matter Expert on TMF training materials, formal and informal processes and tracking tools relating to end user support.

Partner with service providers and internal stakeholders to ensure end user support provided by 3rd party partners is aligned with CDGM requirements, and embed assessment of end user support into oversight of third-party service performance.

Support activities to increase CDGM staff capabilities in relation to end user support, and embed user centric approaches into CDGM service delivery.

Provide support in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs

Act as CDGM point of contact for other projects and initiatives, to ensure engagement and involvement of CDGM as needed.

Requirements

Bachelor’s degree or equivalent and relevant industry experience

English fluency (written, oral) required

Minimum of 5 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.

CRA experience is a plus

Demonstrated success in planning and executing cross functional projects.

High organizational awareness, including experience working in multidisciplinary teams, across cultures and geography.

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. Learn more at https://jobs.iqvia.com