Laura D.

About Laura D.

Dynamic and results-driven Project Manager in Clinical Study Start-up and site maintenance, with over 15 years of experience in significantly enhancing site productivity and leading teams. This most recent experience includes feasibility studies, site identification, regulatory reviews, and site maintenance. I excel at aligning cross-functional objectives and implementing best practices. With a proven ability to interpret and create strategic proposals for clinical operations, I develop comprehensive global resource plans and accurately oversee time-reporting activities. Clinical trial phase experience encompasses screening, Phase I, II, and as well as real-world evidence studies. Therapeutic expertise includes oncology, molecular biology, blood-based assays, solid tumors, hematology, and nephrology. Monitoring experience includes Type I and II Diabetes Mellitus.

Experience

1. Study Startup and Site Maintenance

   Universal Diagnostics S.A.

   Sep 2023 — Present · US

   Achieve timely study start-up and FPI for 175 sites and three studies• Identify barriers to timely study execution and propose effective solutions.• Vendor management of Contract Research Organization site contracts, payments, and payment of CRO adhering to best practices.• Negotiated site budgets and contracts for 120 sites and confirmed monthly site payments for all study sites and vendors.• Manage day-to-day operations of study start-up activities and study execution. • Work with the V.P. of Global Clinical Operations, managing millions of dollars clinical study budget.• TMF activities for two systems, Trial Interactive and CloudByz.• Perform quarterly eTMF reconciliation, providing accuracy and completeness of documents according to eTMF SOP (CloudByz)

Education

• University of Tennessee, Knoxville

  Bachelor of Arts - BA