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
o 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
o 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