Lucy VanSchoyck
Brodheadsville,PA
Summary
Hands on, analytical, reliable professional with over 15 years experience and knowledge of FDA regulations and GCP/GXP. Skilled in implementation and execution of global projects, tough decision making and achievement of goals in challenging environments. Extensive knowledge of supply chain strategies, procurement principles, practices, and procedures. Conversational in French and Italian. Focused project manager bringing several years of developing continuous improvements throughout planning and implementation phases of projects. Demonstrated history of establishing and enforcing adherence to standards of excellence. Well-versed in mentoring and guiding associates to exceed client and stakeholder expectations.
Overview
27
27
years of professional experience
Work History
Lead Client Services Project Manager
Thermo Fisher Scientific
06.2023 - 07.2024
- Independently managed large, complex project portfolio, programs and multiple client projects, planning and delivering at all project stages
- Developed methods to proactively identify, monitor, and evaluate project challenges and partnered with cross functional teams to identify solutions and deliver positive outcomes
- Mentored other team members on project resolution
- Pro-actively defined, tracked, and negotiated expenses, budgets, and revisions in response to project achievements and performance
- Extensive understanding of customer contract terms and conditions; skilled in negotiation skills and techniques and coached others in effective contract management
- Highly skilled at performing and interpreting comprehensive need analyses which reflect an understanding of the customer's target market and value proposition
- Utilize the understanding of CAM best practices to develop new or improve existing business processes and appropriately document and revise or develop associated training materials
- Designed and implemented strategic plans to forecast and supply ancillaries to global clinical trials, using sound supply chain techniques
- Managed portfolios and programs efficiently in different systems to provide accurate high level forecasting information to core team, leadership and the client
- Maintained accountability for individual and team outcomes.
Senior Clinical Supply Chain Manager/Portfolio Lead
Thermo Fisher Scientific
10.2021 - 06.2023
- High Level Understanding of protocols within client portfolio
- Provide oversight of supply/demand planning and forecasting by projecting demand into future, make assumptions based on data, assess impact of new data relative to clinical studies
- Make decisions (with input from the Planners) on what items should be purchased for Central Pool
- Bring recommendations back to the Client for agreed action; execute on decided actions
- Ensure that demand is captured in order to consistently deliver accurate data to planning group (includes new and updated demand)
- Engage business leaders for decisions and/or support as needed
- Identify operational gaps and contribute to resource planning and process improvement
- Act as Escalation Point by bringing in Escalations/Critical Communications (ex
- Projected study disruptions, supply issues) to Tier Board meetings and leadership
- Maintain and update Portfolio level Risk Register, Stakeholder Register, Communication Plan
- Liaise with Sales/AE, Quoting, Strategy, Planning, Procurement, Solutions, Distribution, Team Leads
Clinical Supply Chain Manager
Thermo Fisher Scientific
08.2017 - 09.2021
- Design and implement strategic plans to forecast and source clinical ancillary supplies to global clinical trials using sound supply chain techniques (75% global, 25% domestic)
- Review, interpret and implement supply forecast plans from internal or external source documents and tools
- Plan and manage execution of initial supplies and resupplies for assigned studies
- Identify potential risks, define and execute risk mitigation plans
- Perform study close out activities including returned good reconciliation, inventory destruction processing, and file archiving
- Summarize data, prepare presentations and make recommendations for actions relative to the clinical supply chain
- Negotiate effectively with clients regarding study plan without damaging relationships
- Work with CROs in managing IRT requirements
- Source comparator drug in US and global depots and work with depots to ensure product arrives in country without any hiccups
- Work with both internal and client project teams to ensure consistent communication of clinical trial material supply status
- Identify, recommend, and lead process improvement initiatives
- Support communication of best practice through shared learning sessions, contribution to guidelines and SOPs
- Establish and maintain financial forecasts and monthly billing processes for assigned client projects.
Clinical Supply Chain Project Coordinator
Thermo Fisher Scientific
06.2015 - 08.2017
- Managed inventory and shipment delivery
- Documented and maintained calculation of ancillary use and supply based on varying levels of available data from Sponsors, IVR vendors and Internal FCS departments
- Generated and distributed weekly shipping/inventory reports
- Solved issues and discrepancies with QA, Export, Distribution and Materials Management
- Assisted with project set-up activities
- Processed billing packets for all studies.
Vendor Accreditation Administrator
Olympus America
Center Valley, PA
09.2013 - 09.2014
- Prepared and analyzed project status reports as required and supported leaders with any reporting needed
- Facilitated compliance issues discussions
- Spearheaded development of new processes to address gaps
- Analyzed, communicated and resolved all discrepancies between customer and internal databases
- Collaborated with internal and external entities to ensure all documentation was obtained and correct information provided
- Reviewed facility documents and policies, supporting field requests for information, making credentialing information easily accessible and useful, and reporting on the status of requests.
Regulatory Affairs Associate
ReSearch Pharmaceutical Services, Inc.
Fort Washington, PA
04.2004 - 05.2011
- Supported implementation of electronic document management system
- Developed process, conventions and training for documentation staff
- Managed global documentation team along with training and mentoring team members
- Served as Lead for multiple domestic and international projects as Trial Master File (TMF) Subject Matter Expert
- Acted as departmental liaison for communications and issue resolution between Sponsor and CRO
- Set up and maintenance of TMF documentation via Documentum based EDMS
- Initiated Study Start-Up activities including feasibility, site identification, site contract negotiation, and other study start up activities
- Reviewed initial TMF documents for compilation and submission to Regulatory Affairs
- Conducted interim and final review of TMF files for inspection readiness
- Collaborated with project teams and CROs from study start to completion to ensure regulatory compliance
- Reviewed and compiled information for eBLA appendices
- Worked in conjunction with Clinical Documentation in ensuring discrepancies and issues were reconciled and resolved
- Provided clinical support to Regulatory Affairs for NDA submission
Medical Program Documentation Specialist
Merck & Co., Inc.
Blue Bell, PA
01.2004 - 03.2004
- Collaborated with internal customers to evaluate areas that impact study start-up, for example feasibility, site selection or site contract status and shared information with the project team
- Reviewed and compiled information and forms for appendices of Clinical Study Report
- Set up and maintenance of Trial Master File documentation via Documentum based EDMS
- Initiated Study Start-Up activities including feasibility, site identification, site contract negotiation, and other study start up activities for several trials
- Evaluated site specific consent forms, conducted informed consent negotiations and approved non-substantive changes
- Compiled and shipped regulatory packages to sites, tracked completion of regulatory documents and renewals, resolved issues with regulatory packages and coordinated with clinical teams
- Worked with CRO staff in resolving outstanding issues and deficiencies
- Provided training to CRO staff as well as ongoing advice and guidance.
Senior Manager of Regulatory Compliance
Barton & Polansky Associates, Inc.
New York, NY
02.1997 - 11.2002
- Managed a department consisting of 7 Regulatory Associates and 2 Clerks
- Conducted performance appraisals, development opportunities and provided learning support
- Management of SAE reporting for all studies
- Developed and implemented department SOPs
- Development and implementation of CRA Regulatory Document Training Manual
- Developed and presented material for Investigator Meetings
- Created and implemented company-wide SOPs and department SOPs and processes
- Developed training for new hires in collection of regulatory documents, study start-up and maintenance of central files
- Collaborated with internal customers to evaluate areas that impact study start-up such as feasibility, site selection and contract issues and shared information with the project team
- Trained all newly hired clinical personnel on company and industry specifics and provided ongoing in-service training for Clinical personnel
- Completed thorough review of Sponsor TMFs designated for product submissions
- Conducted random study site audits to ensure compliance with protocol for all studies.
Education
Bachelor of Science in Business Administration /Project Management -
DeVry University
Fort Washington, PASkills
- Implementation and execution of global projects
- Supply chain strategies
- Project management
- Cross-functional team collaboration
- Contract management
- Clinical supply chain management
- Risk mitigation
- Inventory management
- Shipping and logistics
- Process improvement
- Financial forecasting
- SOP development
- Coaching and Mentoring
- Project accountability
- On-time deliverables
- Compliance Monitoring
- Procedure Development
- Contract Management
- Risk Management
- Financial Administration
- Project development
- Work flow planning
- Strategic Planning
- Productivity Improvement
- Stakeholder Communications
- Client Relations
- Budgeting and forecasting
Training
- Drug Development and FDA Regulations (Barnett International)
- Adverse Events: Managing and Reporting (Barnett International)
- Auditing Techniques for Clinical Research Professionals (Barnett International)
- Documentation Management and Control in the Pharmaceutical Industry (Institute for Applied Pharmaceutical Sciences)
- Good Clinical Practice (PERI)
- Ensure Your Trial Documentation Will Pass FDA Inspection (Thompson Publishing Group)
- Foundation in Project Management (IAOCR)
Timeline
Lead Client Services Project Manager
Thermo Fisher Scientific
06.2023 - 07.2024
Senior Clinical Supply Chain Manager/Portfolio Lead
Thermo Fisher Scientific
10.2021 - 06.2023
Clinical Supply Chain Manager
Thermo Fisher Scientific
08.2017 - 09.2021
Clinical Supply Chain Project Coordinator
Thermo Fisher Scientific
06.2015 - 08.2017
Vendor Accreditation Administrator
Olympus America
09.2013 - 09.2014
Regulatory Affairs Associate
ReSearch Pharmaceutical Services, Inc.
04.2004 - 05.2011
Medical Program Documentation Specialist
Merck & Co., Inc.
01.2004 - 03.2004
Senior Manager of Regulatory Compliance
Barton & Polansky Associates, Inc.
02.1997 - 11.2002
Bachelor of Science in Business Administration /Project Management -
DeVry University
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