Wendy George
Clinical Outsourcing Consultant @ Revolution Medicines
About
Detail-driven and goal-oriented manager in clinical research industry with more than 20 years of experience in strategic sourcing, category management, vendor management, contract negotiation and management, cross functional project management, process analysis and reporting, and line management. Leader focused on developing strategic partnerships which deliver high levels of quality, value, operational efficiency and innovation. Excel at leveraging first-class interpersonal communications and relationship management skills to magnify profits and productivity and create efficient, cost-effective solutions for internal and external clients.
United States
Mount Pleasant
Biotechnology
Vendor Onboarding, Market Analysis, Governance, Strategic Thinking, Change Management, Compliance Oversight, Operational Excellence, Vendor Qualification, Outsourcing, Key Accounts, Resolving Issues, Communication, Conflict Resolution, Pharmaceuticals, Team Management, Strategic Negotiations, Category Management, Clinical Development, Clinical Research, Contract Negotiation
Experience

Category Leader IV, Global Strategic Sourcing
Otsuka Pharmaceutical Co., Ltd. contracted through Advanced Clinical
Remote

Sr. Manager, Strategic Clinical Sourcing
Remote based
• Contract lifecycle management; manages clinical contracts and change orders, including active negotiation of scope of work, payment terms and budgets including identification and selection process of clinical vendors such as CROs, central labs, IRT, Imaging, ePRO, etc. • Coordinates bid defenses and proposal review meetings and provides analysis to project teams. • Assists Finance with month-end and budget/forecasting needs, such as accruals, project budgets, etc. • Measures supplier performance utilizing Scorecard/Metric activities; and communicating feedback to the supplier, encourage adaptation on best practices across supplier types and development of continuous process improvements/ maintenance. • Facilitates and executes supplier governance meetings and operating reviews. • Identify/monitor current trends in outsourcing practices in the industry and specific to the Asia Pacific region. • Identifies, develops and implements outsourcing processes and procedures. • Leads and contributes to complex functional or company initiatives and special projects as identified by executive management or business need.

Manager, Vendor Management
• Managed and supported vendor governance at the Operations/Portfolio level. • Developed Relationship Management Plans, Charters, Service Level Agreements, and Key Performance Indicators. • Led or supported program or portfolio level issue resolution, monitored issues, assessed risk levels and reported on trending to senior leadership. • Led vendor management strategy for AbbVie's key service providers. Areas of focus included vendor segmentation, governance, performance management and development. • Collaborated with vendor and business stakeholders to ensure overall effectiveness of vendor services and other initiatives. • Participated in functional and cross-functional initiatives

Manager, Clinical Outsourcing
• Managed vendor relationship across clinical development. • Served as first point of contact for internal customers in the development of outsourcing requirements for Phase I-IV global clinical trials. • Managed and supported vendor governance at the Operations/Portfolio level. • Developed Relationship Management Plans, Charters, Service Level Agreements, and Key Performance Indicators. • Led outsourcing activities across all therapeutic areas, including RFI, RFP, proposal review, bid defense, and contract and budget negotiations. • Negotiated MSAs, Contracts, Work Orders, Service Agreements, and Chang Orders/Amendments with a focus on Business Terms, Scope, and Budget. • Scheduled, organized, and facilitated quarterly joint operational committee (JOC) meetings for eliciting feedback from study teams, quality management groups, and other support functions such as Finance and Legal and tracking action items through to completion for assigned vendors. • Provided cost benchmarking for clinical outsourcing activities using industry based tools or customized analysis. • Led Sourcing Initiatives to evaluate vendor specific categories and new service providers and onboarded new vendors.

Sr. Clinical Outsourcing Consultant
Advanced Clinical (Embedded at Eisai Inc.)
Regionally Based
• Supported internal customers in the development of outsourcing requirements for Phase I-IV global clinical trials. Lead and support the qualification and evaluation process for new service providers. • Led the process of Request for Proposal (RFP) development from service provider selection through final contract execution. Chair proposal review meetings and coordinated all follow-up activities with service providers during the evaluation and selection process. Evaluation included cost analysis, capability assessment, and overall alignment of services with project goals. • Managed the contracting process including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, Change Orders, and Amendments. Coordinate development of service requirements, e.g., statement-of-work, negotiate budgets and payment schedules using costing tools as necessary. • Fostered clear, consistent and open collaboration across extended internal and service provider teams. Engage in service provider relationship and performance management. Participated/led vendor governance meetings. Developed process improvements. • Functioned as an integral part of study management teams involved in up front planning and development of strategic sourcing plans for a program(s), as applicable.

Associate Director Proposals and Budgets
• Maintained and drove high quality and efficient output from the team. Contributed to overall excellence by identifying best practices, developing/recommending to senior management and implementing process, text template and budget tool improvements as well as other initiatives. • Provided senior level oversight, strategic direction and overall proposal development for key accounts and/or large, high priority opportunities. • Monitored team workload ensuring timelines are being met, issue resolution etc. - participated in workload management discussions. • Reviewed/QC of all direct reports deliverables and provided oversight, strategy input, and QC review for team deliverables. • Conducted performance review process for direct staff - developed goals and performance objectives and metrics to assess performance of direct reports. • Participated in negotiations and discussions with clients as needed. • Proposal development as required and maintained knowledge of tools and processes in order to provide guidance and drive improvement. • Provided onboarding for new employees and training for department members.

Senior Outsourcing Manager
Regionally Based
• Managed the contracting process including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, Change Orders, and Amendments. • Responsible for Vendor Selection and management, contracting and negotiating vendor/ CRO agreements (Ph2-4) higher complexity across programs in complex multi region/Global studies. • Functioned as an integral part of study management teams. Involved in up front planning and development of strategic sourcing plans for a program(s), as applicable. • Responsible for generating the Request for Proposal (RFP), performing analysis of the responses, and leading the clinical study team discussion of vendor selection, including preferred pricing and volume rebates. • Worked closely with legal and clinical operations and other relevant functional groups for review and escalation of contract and budget issues. • Create, maintain and modify Purchase Orders and review/approve invoices. • Maintained high level of audit readiness by maintaining department central repository databases for contract tracking purposes, workload management, and metrics tracking. • Served as Subject Matter Expert for Drug Distribution and Site Equipment.

Senior Manager Commercial Operations
PRA Health Sciences (ClinStar LLC)
● Successfully managed the Contracts and Proposals department and provided management, leadership and training to direct reports. ● Developed and led the process for the creation of budgets, change orders, LOIs, and contract/task order text including global and multi-study programs. Provided final approval and sign-off on all budgets. ● Led the process for and created proposals including strategic discussions on how to operationalize global Phase Ib – Phase IV clinical trial studies. ● Understood client requirements and organized and presented deliverables at internal meetings, client meetings, bid defenses, teleconferences, and kick-off meetings. ● Maintained and updated the global costing tool to ensure processes and algorithms were in alignment with current operational realities and client expectations. Participated in process improvements. ● Effectively negotiated the international contracts/task order, start-up agreements, consulting agreements, timelines, project responsibilities, budgets, and payment terms with clients to ensure compliance with established processes and metrics. ● Managed third party relationships with vendors to receive quotes for services (data management, protocol writing, safety providers, IVRS services). ● Demonstrated track record of increasing responsibility and leadership experience. ● Excellent project management skills and capacity to manage/lead multiple projects. ● Wrote and developed budgets for 46 studies in 2012, 39 studies in 2011, 42 studies in 2010, 32 in 2009, and 36 in 2008. ● Negotiated and executed 17 SOWs/contracts executed 39 change orders in 2012.
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