Medtrace - Minneapolis, MN
posted 3 months ago
Join MedTrace as a Director of Clinical Research and play a crucial role in advancing our mission to make 15O-water practically available. As part of our international Clinical Development team based in the US office in Minneapolis, you will collaborate with internal partners, external stakeholders, and physicians to shape the clinical development strategy. This position is pivotal in managing the day-to-day research operations and objectives in support of assigned projects, contributing valuable information and ideas as part of various teams across all projects. You will ensure effective and efficient workflow while adhering to quality standards for both staff and programs, as well as for yourself. In this role, you will be responsible for maintaining responsive interactions with state and federal partners, ensuring compliance with regulatory requirements, and overseeing budgetary aspects including monitoring and tracking projects. You will also be involved in grant and contract development and negotiations, as well as project reporting. Your personal values should align with drive, passion for your work, responsibility, and a commitment to diversity and equality. You will thrive in a dynamic and versatile working environment, shaping your job according to your strengths and qualifications. Key responsibilities include managing the planning, design, and execution of clinical trials, which involves drafting study protocols and reports, managing CROs, overseeing field monitoring activities, and ensuring data quality. You will ensure adherence to good clinical practice (GCP) guidelines, FDA regulations, and standard operating procedures throughout all clinical research activities. Additionally, you will manage relationships with clinical trial sites, principal investigators, and CROs, which includes site selection, contract negotiations, and ongoing communication. You will oversee a team of clinical research professionals, collaborate with other departments to support the overall development strategy, analyze and interpret clinical trial data, and prepare clinical study reports. Staying updated on advances in cardiovascular imaging and relevant regulatory requirements is essential, as is presenting progress reports and tactical/strategic plans to upper management and oversight committees. You will also implement risk management strategies to identify and mitigate potential issues in clinical trials, contributing to the company's overall research and development strategy.