Reporting to the Global Head External Relationship Management, the EDO Relationship Lead is responsible for the management of outsourced activities and deliverables of one or more supported External Relationship Management Teams (ERMT).

Working within a matrix environment, the Expert EDO Relationship Lead is accountable for all operational aspects of 1 or more ERMTs

Supplier Service or Equipment expert within the assigned services within the ERMTs to drive value beyond cost from Novartis’ external supplier base

Supporting the implementation of the agreed outsourcing strategies within the ERMTs

Responsible for supplier governance, management and issue management/escalation across GDD and cross-divisionally as required.

Function as a point of escalation for supplier issues which cannot be resolved at the individual Clinical Trial Teams (CTTs) level

Leverage knowledge, experience and understanding of service category(s) and suppliers to provide support to the operational management within the ERMT(s)

Lead supplier due diligence activities with ERMT(s)

Major activities:

• Responsible for:
  • Management of issue documentation, escalation, and resolution for matters which cannot be resolved at the CTT level; providing direction to CTTs for service specific standards and training
  • Drive root cause analysis of supplier performance issues and look for trending across supplier and service category
  • Lead ERMT Governance and business review meetings, including documentation and communication of supplier performance, meeting logistics and minutes
  • Deputize for EDO UH in leading and managing ERMT owned activities
  • Accountable to maintain appropriate ERMT service-specific content for Study Specifications Worksheet (SSW) templates
  • Function as category expert providing expertise and training to EDO Service Leads on category strategy, SSW content and use, service standards, and special considerations
  • Drive the creation of Novartis standards within a service / functional area
  • Ensures compliance with all required SOPs and business guidance documents
  • Promote ERMT supplier strategy; facilitate supplier selection across the GDD portfolio
  • Act as a coach and mentor to Senior EDO Relationship Lead associates
  • Leadership, as needed, in  ERMT audit / inspection readiness activities

• Provide support for:
• Process improvement and optimization within Novartis and supplier

• Collection and assessment of Key Performance / Key Quality Indicators (KPIs/KQIs)
• Training for internal stakeholders on EDO processes and systems
• Promoting the EDO agenda across GDD through consistent communication of EDO goals and achievements
• Outsourcing initiatives in collaboration with R&D Procurement
• Support EDO Relationship lead with award recommendations to CTTs and Global Clinical Teams (GCTs) based on business requirements
• Development of supplier management plans within ERMT(s) including appropriate governance structures
• Process improvement and harmonization across divisions and functions to ensure compliance with all Novartis policies and procedures

• Lead supplier due diligence activities, as required
  • Timely oversight, completion, and management of assigned supplier qualification and re- qualification requirements
  • Accountable for quality and completeness of qualification and governance documentation in EDO systems
  • Manage and maintain due diligence document templates and tools

Ideal Background:

• Excellent knowledge of GxP and ICH regulations
• Expert knowledge of clinical trial design and mapping to supplier requirements
• Thorough and technical understanding of Novartis specifications for supplier provided services
• Demonstrated leadership with supplier relationship management and/or expert knowledge of specific service areas
• Demonstrated partnering across divisions with internal and external stakeholders
• Demonstrated root cause analysis, problem solving, and solution generation skills
• 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
• Excellent influencing and communication skills

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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.