Kristen Bagby

WORK HISTORY

EDUCATION

ABOUT KRISTEN BAGBY

Trailblazing clinical performance leader & change agent w/ 10+ years of expertise in clinical quality improvement, regulatory compliance, & performance optimization. Driven by an unwavering commitment to elevating healthcare systems, empowering clinical teams, & advancing clinical research, I specialize in turning challenges into measurable success. Passionate about bridging the gap between strategy & execution, I bring a unique ability to inspire change, drive accountability, & implement high-impact solutions that optimize workflows, improve compliance, and enhance trial efficiency. On a mission to drive clinical and research excellence and operational efficiency, I am eager to bring my expertise to advance quality initiatives, streamline processes & lead site activation activities for the successful execution of clinical trials.· Quality/ Process Improvement & Change Management- Expertise in identifying inefficiencies in clinical & operational workflows & leading end-to-end process redesigns that enhance productivity, reduce costs, & improve patient care. Proven mastery in leading & facilitating process improvements while applying quality improvement methodologies (PDSA/root cause analysis).· Site Activation and Regulatory Compliance- Deep knowledge of regulatory frameworks, including FDA, GCP, and ICH guidelines, & compliance standards, including standard operating procedures (SOPs), ensuring adherence for the execution & management of site activation activities.· Audits & Compliance Optimization- Highly adept at conducting compliance audits, performance evaluations, & policy reviews to ensure adherence to regulations. Proven ability to enhance documentation accuracy. · Project Coordination and Timeline Management- Adept at overseeing project planning, monitoring study timelines, & implementing contingency plans to meet critical deadlines. Strong ability to effectively manage multiple projects. · Communication & Stakeholder Engagement- Strong ability to collaborate effectively with investigative sites, sponsors, and regulatory bodies to drive site activation and ensure timely clinical trial execution. Adept at negotiating solutions, motivating stakeholders to meet critical deadlines, and constructively challenging processes when necessary to optimize efficiency and compliance.· Clinical Trial Expertise- Extensive experience in clinical trial operations, encompassing drug development process, site activation, ethical guidelines, & industry regulations, ensuring smooth execution & timely activation of clinical sites.