Lauren Weinstein

About Lauren Weinstein

Results-driven and dedicated clinical research professional with 15+ years of experience…

Experience

1. Associate Director Clinical Operations

   Aura Biosciences

   Jan 2024 — Present · Boston, MA, US

   Planning, implementation and execution of global oncology clinical trials from initiation to completion in alignment with Aura\'s drug development strategy-Partner closely with cross-functional stakeholders, including Clinical Development, Regulatory, Quality, Medical Affairs, etc. to ensure seamless trial execution-Provide leadership, mentorship and guidance to the global clinical operations team, fostering a collaborative and high-performing culture-Select, oversee, and manage relationships with external vendors, including contract research organizations, central imaging and other service providers-Ensure compliance with regional regulatory requirements, ICH-GCP guidelines and Aura SOPs-Proactively implement quality control measures to maintain high standards of data integrity and participant safety-Contribute to the development and execution of clinical strategies aligned with the overall development plan and company goals-Provide input on clinical protocols, investigator brochures, and other key documents-Develop, manage and forecast clinical trial budgets, ensuring cost-effectiveness and efficient resource allocation-Effectively communicate with internal and external stakeholders, including study sites to ensure clear and transparent flow of information in alignment with study expectations/timelines-Assist in the review and preparation of Master Service Agreements and Vendor Work Orders-Present updates to senior management on a routine basis-Support Clinical Leadership Team in the preparation and review of key data/results-Participate in the development of eCRF and completion guidelines as well as user acceptance testing-Develop and oversee the implementation of clinical processes and procedures including site budgets, investigator payments, etc-Conduct periodic clinical review of data entered in the EDC system.