Novo Nordisk - Irvine, CA
posted 2 months ago
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is a dynamic and diverse group dedicated to improving patient outcomes through innovative clinical research. This position plays a crucial role in ensuring the quality and integrity of clinical trials, focusing on patient safety, data reliability, and regulatory compliance. The successful candidate will take ownership of North America Clinical Development (NACD) goals, contributing to the successful delivery of studies within the clinical trial portfolio. This role involves engaging in improvement and innovation projects, adapting to a continually changing environment, and leveraging advanced tools and technology to enhance clinical research processes. In this position, you will be responsible for managing relationships with external partners, including clinical trial site staff and research vendors, as well as internal stakeholders across various departments. You will provide excellent customer service and build strong working relationships to facilitate the planning and implementation of clinical trials. Your essential functions will include delivering quality-driven clinical trial services, implementing proactive risk management strategies, ensuring compliance with safety reporting, and verifying the accuracy of data collected at trial sites. You will also participate in audit and inspection activities, collaborating with stakeholders to develop corrective action plans as needed. This role requires a proactive approach to recruitment and retention strategies to meet enrollment targets, as well as a commitment to staying updated on new practices and technologies in the field. The position demands a strong understanding of medical and scientific concepts, excellent communication skills, and the ability to balance multiple priorities effectively. As part of a job family, the title and level will be determined based on experience and business needs, with competitive compensation and benefits offered.