Apex, North Carolina, United States
• Lead feasibility assessments and predictive enrollment modeling to optimize protocol design, country strategy, and site selection. • Integrate competitive intelligence, historical performance, and operational benchmarks to strengthen startup and enrollment assumptions. • Built interactive KPI/KQI dashboards that reduced manual reporting time by 95% and enabled proactive risk mitigation. • Partner with Clinical Operations, Development, and Biometrics to refine feasibility inputs and support strategic decision‑making.
Contracted to Johnson & Johnson as Sr. Feasibility Analytics Manger • Managed data science resources and activities from protocol development through study closure to enhance trial efficiency and patient enrollment. • Collaborated with stakeholders to develop custom dashboards for multiple studies and portfolios, aiding in study tracking (site openings, subject enrollment, and impact of protocol amendments) and enhancing site engagement. • Delivered on-time, on-budget results while embedding custom data science solutions into trial operations. • Built complex enrollment models incorporating multiple cohorts and seasonality.
• Led site identification, selection, and CDA negotiations while managing cross‑functional resources, timelines, and budgets. • Oversaw financial planning, resource allocation, and development of project systems, databases, and tracking tools. • Successfully managed challenging stakeholder relationships, resolving sponsor concerns by implementing innovative solutions tailored to meet unique study requirements, resulting in heightened sponsor satisfaction and potential future collaboration opportunities. • Trained and mentored global teams on protocols and site identification processes.
• Leadership for the development and refinement of Site Intelligence Data Assets, Systems, Processes and Tools and the execution of department improvement initiatives to ensure industry leading site intelligence to support new business wins and to optimize site selection • Analysis of business needs to develop requirements and enhancements for Site Intelligence systems and driving of their implementation • Project planning, leading and management for Site Intelligence Initiatives • Technical leadership, mentorship, and training to the Site Intelligence team and other internal customers including development of training and mentoring programs and contribution to the maintenance of system documentation and manuals. • Design and implementation of sponsor specific compliance check process • Utilize LEAN Business process methodology to streamline investigator compliance, sponsor specific Due Diligence and compliance with various Anti-Bribery Laws (ABL), including the Foreign Corrupt Practice Act (FCPA) • Department audit lead on sponsor pre-qualification and study/process specific audits (client facing) as well as internal audits • Business Process Lead on sponsor specific clinical data exchange, specifically using SQL and Business Intelligence reports for data stewarding and mastering of investigator roles • Create powerful visualizations on large data sets with Spotfire and R • Subject Matter Expert (SME) for the sponsor specific Due Diligence Process as well as US investigator compliance issues and sanctions processes and SOP’s • Formal LMS trainer for sponsor specific due diligence as well as a trainer investigator compliance and other related processes • Owner/manager of four service desks • Utilize data mining techniques to improve data collection, promoting more accurate data • Review monthly metrics to ensure sponsor specific investigator compliance • Serve as point of contact for Anti-Bribery (ABL) and Foreign Corrupt Processes Act (FCPA) screening process
• Monitor and review Food and Drug Administration (FDA), Office of Inspector General (OIG) and other regulatory websites for compliance issues and update this information in CTMS • Perform sponsor-specific Due Diligence reviews of potential investigators prior to site activation date • Cross-check feasibility investigator site lists to eliminate duplicates • Review, format, and enter Investigator information for entry in the CTMS • Create/maintain/update User Guides, manuals, and service desk ticket submission forms • Maintain database cleanliness by removing duplicates, importing and updating records from external sources
• Interviewed patients after surgery, collecting key data points for the program • Ensured delivery to clinical study plans were aligned to protocol • Gathered information and samples in clinical setting • Collected and analyzed large data sets using t-tests and ANOVAs to determine significance difference • Trained new lab technicians on protocols including: fatty acid oxidations, BCA assays, and western blots • Performed fatty acid oxidations to compare glucose uptake sensitivity in obese diabetics and non-diabetics