• Lead and manage multiple clinical trials from initiation through to completion, ensuring adherence to study timelines and budgets. • Collaborate with investigators, vendors, and cross-functional teams to ensure study execution and operational excellence including implementation of best practices such as quality by design. • Oversee the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and clinical study reports. • Support creation of investigator brochures, clinical evaluation reports, publications and other documentation such as annual reports as applicable. • In partnership with R&D Program Management, develop and drive cross functional study timelines related to trial setup and execution. • Drive the cross functional internal study team ensuring appropriate alignment, risk management and coordination across all participating functions. • Successfully interface with Data Management, Biostatistics and Clinical Monitors to ensure seamless monitoring and data cleaning initiatives to meet study deliverables and timelines. • Foster a collaborative team environment focused on operational efficiency and continuous improvement. • Ensure that clinical trials are conducted in compliance with all applicable regulations and ISO 14155 and ICH-GCP guidelines as applicable. • Lead submissions of clinical trial documents to central IRB/IECs as applicable and ensure insurance and recruitment materials are prepared appropriately. • Support the preparation and submission of clinical trial applications, including IDEs, PMAs, 501K, INDs, and other regulatory documents with functional leads from regulatory affairs. • Manage interactions with Regulatory Affairs and external vendors to ensure timely submissions and approvals. • Develop and manage clinical trial budgets, ensuring efficient use of resources and timely financial reporting. • Monitor and control trial costs to ensure alignment with project forecasts and company objectives. • Negotiate contracts and budgets with clinical vendors and investigators. • Oversee the selection and management of clinical research sites and clinical vendors (CROs, laboratories, etc.) and ensure they meet performance expectations. • Develop strong relationships with clinical sites and external partners to ensure aggressive site startup, high-quality data collection and trial conduct. • Perform risk assessment and management, addressing issues proactively to mitigate operational issues.