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Management Strategies for Vendor Oversight

5-week online course | 2 hours per week

1 July - 5 August 2019

Online Academy

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Module 1: Introduction to outsourcing
  • The basics of outsourcing models and strategies
  • What to outsource: selection, goals and benchmarking
  • Vendor selection & management essentials to include timeframes
  • Regulatory Requirements and Quality expectations
  • Basics of vendor oversight and vendor management?
  • Metrics to drive transparent outsourcing
  • Vendor Governance

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Module 2: Meeting regulatory expectations
  • Examining EU and US regulatory expectations and requirements
  • Exploring the evolution of vendor oversight: sponsors maintaining full accountability even with the complexity of outsourcing
  • Understanding transfer of obligations rather than transfer of responsibilities
  • Case studies: Examples of cases where the sponsor has failed to comply with regulation / received warning letters
  • How can sponsors ensure meeting regulatory expectations?

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Module 3: Selection of the right outsourcing partners
  • Start with the end goal as a focus
  • Selecting a partner to fit your defined strategy
  • RFI, RFP
  • Bid Defence
  • Vendor capabilities assessment
  • Site inspections
  • Financial assessment and mock bids
  • Cost management versus getting it right first time
  • Core elements for contracts
  • Quality Agreements
  • Identifying, understanding and managing risk

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Module 4: Vendor management: What are the key components of vendor management?
  • Vendor management: What are the key components of Vendor Management?
  • RACI
  • Ensuring and enabling operational deliverables
  • Monitoring and documentation of goals, deliverables and quality
  • What is the overarching concept for vendor management?
  • Operational Metrics
  • Achieving effective management across multiple service providers
  • Issue management and effective escalation processes

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Module 5: Vendor oversight: What are the key components of vendor oversight?
  • What is difference between vendor management and vendor oversight?
  • What is defined as success for vendor oversight?
  • Define your oversight philosophy
  • Demonstrating control to inspectors
  • Effective shared risk approaches to vendor oversight: ‘Skin in the game’
  • Hands on/hands off - does it matter?
  • Auditing strategy: Reaffirmation of vendor capabilities and CAPA management

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Module 6: What is governance? Implementing an effective governance structure
  • Ensuring organizational alignment to outsourcing strategy
  • What is required for effective governance of vendors
  • Designing a model to effectively manage and oversee multiple vendors
  • Roles and responsibilities in vendor management
  • Ensuring complementary relationships between QA and outsourcing
  • Business continuity

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Module 7: Risk Management for Clinical Outsourcing
  • Risk Management for Outsourcing
  • Risk Identification
  • Risk Impact Mitigation through Risk Management
  • Risk Management Plan

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Module 8: Maintaining healthy business relationships
  • Success strategies for effective communication
  • The right level of transparency
  • Overcoming challenges with change management
  • Case studies: Differing approaches taken by vendors

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Module 9: Using metrics effectively when outsourcing
  • Metrics to measure your performance
  • Metrics to measure vendor’s performance
  • Metrics to drive transparency
  • Metrics to drive trust

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Module 10: High level legal and financial considerations when outsourcing
  • Development of a contract
  • Key documents
  • Legal terms
  • Typical legal issues and how to overcome them
  • Financial Oversight