Kuleszynski

Principal Clinical Trial Manager @Exact Sciences

Madison, WI, US

Plans and executes in-vitro diagnostic studies ranging from clinical validation trials to $150M large pivotal trials used to support PMA submissions and other corporate goals. Effectively manages CRO and other third-party activities including RFP, selection, contracting, and ongoing oversight of delegated work. Serves as a mentor to other Clinical Trial Managers (CTM), partnering with leadership to improve CTM engagement and promote employee development. Proposes and maintains timelines, resource projections, and budgets for assigned programs (to include tracking and approval of all vendor and site payments). Ensures operational and regulatory integrity of assigned studies, maintains storyboards for audit readiness, and participates in inspections, as needed. Develops trial documents (e.g, Monitoring Plan, TMF Plan, Vendor Oversight Plan) using KPIs/metrics that are appropriate, comprehensive, and study-specific. Facilitates completion of database development, statistical analysis, and the clinical study report in collaboration with Data Management & Clinical Biostatistics. Reviews, updates, and authors Standard Operating Procedures, Work Instructions, and Reference documents according to best practices and updated guidelines. Lead the implementation of CTMS, eTMF, Payments, and EDC systems, including associated workflows, maintaining role as subject-matter-expert post-launch.

The Johns Hopkins University

Master of Science - MS, Research Administration

The Johns Hopkins University

Bachelor's Degree, Public Health Studies