Kyle Webb

About Kyle Webb

I help clinical affairs teams and medical technology organizations craft, implement, and optimize their clinical strategy to expand evidence and drive market adoption of their products. In the intricate world of clinical affairs and study management, where challenges abound and priorities multiply by the minute, I partner with key stakeholders to promptly execute and dive deep across a spectrum of clinical affairs initiatives. Are you starting from scratch, requiring the building of clinical evidence for a new product or value proposition? I will help craft a comprehensive clinical strategy plan aligned with your business objectives, guiding you through the entire process and propose timelines and roadmaps.Are you designing and implementing a new study with tight deadlines and limited resources? I will guide you through the complex clinical study development process, from protocol design to site initiation and all deliverables in between, ensuring your study meets deadlines and is set up for success.Are you or your clinical affairs team members overwhelmed amidst a sea of competing priorities? I will ease your workload, solving problems, writing protocols or reports, optimizing startup or operations, etc, to keep you on track with your goals. Does your startup need immediate project development or execution without committing to full-time hires? I will provide the clinical strategy and study management expertise and support you need to accelerate project development/execution, cover gaps, and help you efficiently achieve project goals. My 17+ year journey with clinical affairs and research includes industry and academic roles at Medtronic, Intuitive, and Emory University. Not only am I known for being a clinical strategist from the view, but I also thrive in the nitty-gritty details of study operations, meticulously fine-tuning all the essential elements that make a clinical study thrive?Let\'s connect and explore the possibilities. I am eager to understand your unique clinical affairs needs, regardless of scale. For additional details, please visit

Experience

1. Owner, Principal Consultant

   Kwclinical

   Aug 2023 — Present · Lafayette, CO, US

   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

Education

• The University of Tulsa

  Bachelor of Science (BS), Exercise and Sports Science

• Wake Forest University

  Master of Science (MS), Health and Exercise Science

Skills

• Research Proposals
• Medical Devices
• Clinical Research
• Clinical Monitoring
• Orthopedics
• Project Management
• Regulatory Submissions
• Research
• Research Design
• Program Management
• Ich-Gcp
• Clinical Trials
• Compliance Research
• Research Administration
• Healthcare
• Protocol
• Edc