Kyle Webb

Collaborates with clients within the medical technology industry, offering services in clinical affairs and clinical study management to support business strategy by delivering clinical evidence for product approval and market adoption. Provides expert consulting and contract services including but not limited to: •Clinical strategy and planning with both program and project requirements considered •Design and review of study documents and tools (protocols, CRFs, ICF, plans, reports, etc) •Contract/budget development and negotiation with sites and vendors •Site and vendor feasibility, selection, and management •Management and oversight of vendors and all study operations throughout the lifecycle •Optimization of study-startup and site initiation activities •Sponsor, site, and vendor communication regarding study progress, challenges, risks, priorities •FDA submissions for initial submissions, amendments, and annual reports •Training and mentoring of sponsor teams, monitors, investigators, and coordinators •Monitoring oversight and IMV report review •Publication strategy and manuscript development, data listing review, final data cleaning •Cross-functional collaboration with clinical and product development teams

Holding company committed to acquiring and stewarding small businesses with care, operational excellence, and a long-term ownership mindset.

Developed, planned, and executed evidence generation strategy for IDE, NSR pre-market, and post-market, procedure- and product-focused clinical studies supporting robotic-assisted medical technology. •Led end-to-end clinical operations for complex first-of-their-kind Intuitive studies from design to final deliverables including reports, podiums, manuscripts, and FDA submissions and clearances. •Guided cross-functional teams, fostering inclusive teamwork and strategic direction, to ensure timely, budget-compliant, and standards-adherent project delivery. •Oversaw clinical studies to include activities of site monitors, clinical vendors, review and approval of site visit reports, selection and coordination of Data Safety Monitors. •Tracked and reported progress of studies to internal stakeholders, to include patient screening, enrollment, data collection, protocol compliance, device accountability, and adverse events. •Planned and coordinated investigator, CRA, and CRC trainings and meetings. •Built partnerships with commercial teams to identify potential study investigators and KOLs. •Validated research methodology and built sustainable relationships with KOLs and investigators. •Built a comprehensive forecast and tracking tool to efficiently monitor enrollment and spend. •Built a surgical proficiency technical assessment and filesharing process and formed a review panel of KOL surgeons to access, score, and return assessments.

Owned comprehensive global clinical strategy for the emerging Health Informatics & Monitoring division designed to build clinical evidence and drive market adoption. •Delivered expert clinical study management for eight studies including: scope, schedule, budget, risk/resource management, site selection, study execution, vendor management, protocol and study report authorship, and other relevant deliverables. •Led clinical strategy designed to benchmark and enhance an acquired wearable monitoring device. Output from a cadence of studies provided key technical limitations which drove decisions to improve the product and its algorithms. •Played a pivotal role within a program team commissioned to assess product market readiness from a clinical, technical, and sales perspective. Developed and executed a two-phased study on an expedited timeline providing key recommendations for a critical business decision. •Demonstrated the ability to strategically align with business value propositions and an ability to effectively adjust to frequently changing business priorities. •Served on cross-functional product development teams as clinical affairs lead for activities including MDR readiness assessment, PMCF, CER, claims matrix development, and risk management assessment documentation.

Led the clinical research division, overseeing 100+ protocols and team performance and mentoring. Managed award administration including proposal development, budget negotiation, reporting and spend. •Advised faculty on research design, feasibility, industry deliverables, and GCP compliance. •Developed and implemented SOP’s for self-monitoring to assess IRB and GCP compliance. •Increased number of funded research proposals by 60% in FY13 and 100% in FY14. •Expanded team quickly and grew grant and contract funding from $333k in FY13 to $511k in FY14. •Increased efficiency and security of data management by implementing web-based data collection tools, developed database to monitor and track all research projects.

Performed dual roles in research administration and project management. Liaison for investigators to industry device and drug partners, CROs, and internal oversight committees. •Guided study teams through: writing of protocols, grant proposals, and data collection forms; regulatory submissions; and study execution. •Resolved obstacles related to trial participation, protocol adherence, and compliance. •Performed analysis of complex research protocols for budget development and sponsor negotiation.