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Expert Systems, Process, Operations, Training Lead

IQVIA Holdings Inc.

Reading, United Kingdom

Job Purpose:

Reporting to the EDO (External Development Operations) Head, the Expert EDO SPOT Lead is responsible for the creation, implementation and management of EDO systems, processes, and training to support all operational activities within EDO. Drives consistency among EDO Supplier Leads and EDO Relationship leads by ensuring standards are developed and followed. Drives participation and input from contacts in Country Organizations to ensure understanding and adherence of EDO systems, process, and training

Major Accountabilities:

  • All EDO SPOTs will be responsible to support the operations of the EDO group by performing the following:
    • Support collection and assessment of Key Performance / Key Quality Indicators (KPIs/KQIs) for EDO and supplier data
    • Participate in continuous improvement initiatives and other management initiatives
    • Coordinate the creation of sponsor standards with support from EDO team members
    • Process improvement and harmonization across divisions and functions to ensure compliance with all sponsor policies and procedures
  • Activities of individual EDO SPOT members may vary based on focus areas, including but not limited to:
    • EDO Systems

      Drive consistency and compliance with EDO SOPs to ensure supplier documentation and assessments are accurate and compliant with current regulations and quality modules

    • EDO Processes, Tools, Templates

      Partner closely with global quality and local country contacts to ensure SOPs/Working Practices are in place and timely training and adherence is maintained within EDO and cross-functionally, as required.

      Creation, maintenance and training for EDO tools and templates to support consistency and compliance with EDO SOPs, governance, and operations.

      Represent the EDO group to review and contribute to processes in other GDO units which impact supplier operations

  • Key Performance Indicators:

  • Robust processes which meet the needs of Trial Management, Procurement, QA, and other stakeholders
  • Consistent operations within EDO and partner organizations (NIBR, Sandoz, Country Operations)
  • Robust processes, systems to capture and measure the resolution, escalation, and communication of supplier quality/performance issues
  • Contribute to continuous improvements/enhancements to benefit business community
  • Complete documentation for continuous process improvements and harmonization across EDO

  • Ideal Background:

  • Education (minimum/desirable): Minimum of a Bachelor’s degree in a relevant field, such as a scientific or health care discipline

  • Languages:

    Fluent English (oral and written)

    Experience/Professional requirement:

  • 10+ years working experience and excellent knowledge of the clinical operation processes, systems, regulatory requirements, and supplier related activities
  • Excellent knowledge of GxP and ICH regulations
  • Strong knowledge of clinical trial design and mapping to supplier requirements
  • Operational excellence within a global organization
  • Demonstrated partnering across divisions with internal and external stakeholders
  • History of successfully working in a cross-functional global team and proven ability to function in matrix structure organization
  • Leadership to deliver projects according to required and deliverables
  • Quality mind-set and detail oriented to meet or exceed regulatory requirements
  • Experience in driving process improvements

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

Job posted: 2021-03-30

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