O. R.

• Directed and executed clinical trial operations across start-up through closeout, including site qualification, initiation, and monitoring oversight, ensuring enrollment goals and data integrity were achieved. • Negotiated and managed study budgets, contracts, and vendor performance, ensuring all clinical studies were delivered within scope, budget, and timelines while maintaining GCP and FDA compliance. • Managed vendor relationships and performance, coordinating with CROs, laboratories, and suppliers to align deliverables, resolve issues, and optimize study execution. • Led the Clinical Operations team through a rigorous FDA audit, resulting in no findings demonstrating comprehensive TMF management, data integrity, and regulatory compliance.

• Oversaw clinical trial execution across start-up through closeout, ensuring protocol compliance, data integrity, and adherence to GCP and regulatory standards. • Managed CRO oversight and study team coordination, including reviewing site feasibility assessments and contributing to site selection decisions, leading team meetings, monitoring visit planning, report review, and issue resolution to maintain study timelines and quality deliverables. • Developed and implemented standardized processes for site activation, IP management, and documentation control—reducing start-up delays and shipping costs by improving site readiness and accelerating study activation timelines.

• Oversaw clinical study execution for IVD and diagnostic trials, including site start-up, initiation, monitoring, and closeout to ensure data accuracy, protocol adherence, and GCP compliance. • Developed and authored study-specific documentation—including source worksheets, monitoring tools, and visit report templates—used to standardize data capture and streamline monitoring across studies. • Led site start-up activities, managing regulatory submissions, essential document collection, and investigator training to accelerate activation and readiness. • Established and maintained an essential document tracking system to ensure all required licenses, GCP training, and IRB approvals remained current and complete prior to site activation and throughout the study. • Performed site qualification, initiation, monitoring, and closeout visits, verifying protocol adherence, subject safety, and accurate reporting of AEs/SAEs while ensuring inspection-ready documentation.

• Managed multi-site clinical trials across multiple therapeutic areas, overseeing start-up through closeout to ensure compliance with study protocols, GCP, and regulatory requirements. • Collaborated with IT to design, build, and test study-specific eCRFs and EDC systems, ensuring accurate data capture, protocol alignment, and ease of monitoring. • Managed site budgets and payment tracking, ensuring investigators were compensated accurately and promptly for completed study activities in accordance with contracts. • Performed site qualification, initiation, monitoring, and closeout visits, verifying protocol adherence, subject safety, and accurate reporting of AEs/SAEs while ensuring inspection-ready documentation. • Led preparation for investigator meetings and delivered educational presentations, as needed, regarding regulatory requirements, safety reporting, or other trial-specific information.

• Established a new clinical research department from the ground up, developing operational processes, site infrastructure, and study workflows to support investigator-led clinical trials. • Identified and secured new study opportunities by researching ClinicalTrials.gov and directly engaging sponsors to add the site to ongoing and upcoming trials. • Recruited principal investigators across multiple therapeutic areas to expand site capabilities and study diversity, while building a network of physician referral partners. • Coordinated all site-level start-up and regulatory activities, including IRB submissions, essential document management, and subject recruitment.