Stephanie Weber Email and Phone Number

• Developed and implemented the SampleGISTICSTM Services line of business of LabConnect; owner/entrepreneur to develop tracking services, technology, and systems. • Designed and managed sample tracking pricing structure, budget strategy for proposals and P&L’s for the line of business.• Developed the operational strategy, business processes, and systems for overall sample tracking services including tracking, digital pens, digital requisition set up and execution, established metrics and set performance targets.• Implemented data-driven analytical tools and systems to continuously monitor operations, identify inefficiencies, and developed optimization strategies, to meet LabConnect annual goals.• Industry leading expertise for webinars and speaking engagements at conferences.• Hiring, assignment, training, and mentoring of SampleGISTICSTM staff.• Oversaw client relationships and programs for sample tracking services and site compliance.• Developed and maintained proprietary software, SharePoint and other tools; oversaw Digital Form Creation/Printing/Mapping/Coding/validation of forms for digital pen study set ups.• Interfaced with laboratory, customer service, business development, project initiation, internal and external project management, information technology, and data management personnel.• Defined sample tracking needs during budget creation and/or study set up. • QC of all protocol related documents, oversaw internal/external issue escalation and resolution.• Oversight of communications on project status and deliverables for multiple internal departments.

• Promotion to above, comparable activities

• Direct supervision of the Early Development Services Project Management, Data Management, and SampleGISTICSTM Operations groups and their respective clinical trial projects.• Responsible for EDS line of business financials and operations; hiring, training, mentoring and retention of staff, including oversight of training compliance. • Ensured EDS annual goals were managed and tracked. • Oversaw client relationships and program; participate in quality audits.• Oversaw the planning and execution of next generation EDS tracking tools and services• Senior Leadership meetings to stay informed of changes affecting operations.• Oversaw development and maintenance of all project-related documentation (includes proprietary software, SharePoint and other tools).• Developed and conducted training and SampleGISTICSTM demos for internal and external stakeholders.• Interfaced with laboratory, customer service, business development, project initiation, internal and external project management, information technology, and data management personnel.• Proposal development, with clinical study managers to define early development and/or sample tracking needs during budget creation and/or study set up.• Digital Form Creation/Printing/Mapping/Coding/validation of forms for digital pen study set ups.• Primary project contact for EDS services, issue escalation/resolution, troubleshooting of digital pen installation issues, timely technical support to the sites as needed. • Ensured samples were collected as per the visit schedule and agreement, using appropriate kits, documented accurately, and tracked for appropriate testing and data analysis.• Ensure smooth operations of multiple projects simultaneously on a global basis.• Oversaw the communication on project status and deliverables amongst multiple internal departments; worked with client clinical operational team members to ensure appropriate communication channels were maintained and reporting schedules were followed.

• Worked with the Chief Development Officer and Scientific Operations/Early Development Services team to lead operational execution of client’s biomarkers programs and early development services. • Managed project team activities to client’s specifications, ensured deliverables were on time and within budget. • Interfaced with laboratory, customer service, business development, external project management, information technology, and data management personnel. Main contact for clients during sample tracking requirements during project set-up.• Assured new clinical test procedures and new IT database validation were completed and acceptable prior to specimen receipt and reporting.

• Same duties as above, promoted as a result of excellent performance.

• Worked closely with the Associate Director (AD) of Biomarkers to provide operational execution of client’s biomarkers program aligned with Central Laboratory services. • Managed activities to client’s specifications, ensured quality deliverables on time and within budget. • Coordinated with AD Biomarkers to develop integrated biomarker plans, provide technical support to the clinical sites, track biomarker samples from collection to analysis, and assist with the relevant data management components. • Defined biomarker needs, developed training materials for investigator’s sites and internal staff. • Ensured that the biomarker samples are being collected as per the visit schedule, using the appropriate kits, documented accurately, and tracked for appropriate testing and data analysis. • Helped develop an appropriate sample tracking program for client biomarker samples, liaise with other departments as applicable (e.g. data and project management, information technology)• Coordinated specimen transfer and reporting with external referral laboratories.• Created manual sample tracking solution for a client, increasing efficiency by more than 50%.• Automated the sample tracking solution using digital pen inputs on a global scale.• Business Intelligence project management for the design of a database interface for automation of subject and sample tracking.

• Worked with Account Executives during proposal phase to ensure proper science and logistics. • Acted as liaison between the clinical trial team and key stakeholders. • Prepared fee schedules and scopes of work prior to submission to clients.• Assigned to high profile studies where timelines and deliverables were compromised and turned them into well-organized, functioning studies with on-time delivery and client satisfaction.• Worked with FDA auditor for high profile study during audit for NDA filing. • Assisted in streamlining processes within the Project Management and between other departments.

• Developed and executed Project Plans ensuring compliance with GCP and GLP standards and client expectations per study protocol. • Managed laboratory reporting and assured efficient and timely management of projects/reports within specified timelines from study start up to study close out. • Managed metrics or lab reporting, queries, turnaround times, shipping, lab kits and cost analysis.• Assisted or led initiatives to improve processes and SOP’s.• Reorganized Kit/Shipping area for lab kit production and specimen shipping/receiving, improved efficiency by 40%, led pilot to improve cost effectiveness of shipping containers for specimens.

• Managed Central Laboratory deliverables, top Project Manager assigned to manage over 20 studies number one revenue generator within 6 months of employment.