Job Summary
- The Senior Manager, Sourcing Risk & Compliance (SRC) will support the design and delivery of a robust vendor engagement infrastructure (processes, systems/tools) for Business & Vendor Strategy Management customers in areas such as business process support, vendor assessment & onboarding, sourcing strategy framework, sourcing & contract compliance and audit/inspection support.
Job Responsibilities
- Monitor and support compliance with sourcing and contracting
- Support audit/inspections/litigation readiness and responses
- Support development and execution of suite of vendor engagement tools to enable better transparency, study and functional line planning
- Support the review, oversight, monitoring and remediation of QMS09 business process
- Support the development of and execution of a fit for purpose vendor assessment process
- Lead risk management activities for vendor engagements
- Provide guidance and expertise to teams for required vendor onboarding and engagement activities
- Support design of fit-for-purpose governance and oversight which hold vendors accountable to relationship commitments and maintains line of sight into performance and quality issues
- Design new processes for Business Development engagements and FCPA processes and train resources to champion, execute and oversee respective areas
Qualifications
- Bachelor’s degree is required. An advanced degree is preferred.
- 8+ years required If Bachelor’s Degree OR 4+ years clinical trial experience required with advanced degree.
- Extensive background in clinical trial conduct, global clinical trial operations, and a thorough understanding of the processes associated with project and study management, monitoring, clinical and regulatory operations
- Demonstrated experience and understanding of risk management within clinical trial execution
- Business experience and understanding of vendor engagement and contracting processes
- Good Clinical Practice (GCP), quality systems infrastructure, and 3rd party supplier management experience
- Ability to support document requests and create tools for internal audits, regulatory agency inspections, and litigation
- Excellent analytical management skills
- Demonstrated sound business acumen and judgement
- Models key behaviors of customer focus, integrity and trust
- Deals with ambiguity is creative and has ability to adapt in real-time
- Drives for results, plans, manages and measures work
- Multi-tasking; prioritizing; coping with high work volume
- Ability to meet tight deadlines
- Ability to work autonomously as well as working within a team
- General knowledge of applying continuous improvement tools to business process improvements/business process re-engineering
- Demonstrated experience to manage and improve large complex processes and/or business operating models
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