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Job Purpose

Responsible for efficient and appropriate analysis of Trial Master Files (TMF) data and critical thinking to inform on trends and determine solutions. Have a quality mindset but be able to focus on supporting riskiest areas first. Work in a changing environment with evolving processes and changing priorities. Translate business needs into TMF process requirements.

Main Responsibilities include:

• Management and operational oversight of clinical trial platform technologies, specifically the Global safety Notification Portal and TMF,  including interaction with vendor and vendor oversight
• Trouble shooting/problem solving of issues raised by business on systems and supporting processes, including escalation as required
• Cross functional working (CSAR, DTI & Business)​
• Assist with response to questions and findings from audits and inspections
• Contribute to the continuous improvement of Clinical Systems & Analytical Reporting Manager (CSAR) and the wider Development organization through information sharing, training and education​
• Maintaining standard business processes within GDO Systems to ensure compliance to regulatory bodies ​​
• Participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting GDO ​
• Independent Activities:
  • Perform quality review of study TMFs focussing on TMF health indicators
  • Review data/reports to identify and highlight trending deficient areas, plan the prioritization and contact study teams
  • Respond to request for review of study’s TMF process related plans:
    •  E.g. TMF Management Plan, Study specific Index
    •  Act as liaison for TMF transfers
• Study Team Interactions:
  • Development and provision of monthly TMF health indicator-based dashboards to study teams and clinical program leads
  • Follow up on trending areas to establish and report back root cause
    • Drive study teams to plan actions and remediation
    • Escalate non resolution of risky areas as relates to TMF
    • Contribute to audit/inspection needs as directed by TMF Ops Snr Mgr/Dir
  • Arrange kick off calls for study start up and closure, and facilitate ad hoc meetings with study manager/team
  • Address or triage study team TMF related questions
• Functional Team:
  • Participate in review of TMF process and/or Veeva eTMF system enhancement
  • Feedback with ideas on the training roll-out
  • Provide feedback and share learnings
    • E.g. trends in quality findings, process suggestions. Industry intelligence, re-training needs

Ideal Background:

• Thorough knowledge of clinical Trial Master File process/activities, regulatory requirements and Good Clinical Practice
• Advanced knowledge of clinical documentation and reporting
• Knowledge of applicable research and regulatory environments, i.e. International Conference on Harmonization (ICH), Good Clinical Practice (GCP)
• Good understanding of technical processes and PC environment including Microsoft suite of products
• Knowledge of the national and international data protection legislation
• Advanced ability to work both independently and in matrix team setting
• Experience with project work or project management in a global, cross-functional multicultural and international matrix organization
• Ability to handle multiple tasks and projects within defined timelines and balance competing priorities
• Excellent communication, organization and tracking skills
• Minimum 6 years of experience with document management systems and excellent understanding of system structures and generic document management functionality

Education:

• Bachelor’s degree in life science/healthcare is required; with minimum 5 years’ experience in clinical development/clinical operations.
• Fluent written and oral English

This role is not eligible for UK visa sponsorship

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