Irvine, California, United States
The Clinical Research Manager role requires leadership experience in clinical research, with a focus on electrophysiology. Candidates should be adept at managing study programs, ensuring compliance with procedures, and monitoring studies based on data needs. Experience in protocol development, cross-functional collaboration for approvals, and data review is essential. The role also necessitates the ability to represent the program in meetings and provide leadership for scientific aspects, including study design review and ensuring scientific accuracy in reports. Familiarity with managing investigational products and trial materials, as well as collaborating with key opinion leaders and external researchers, is beneficial. The position requires a hybrid work schedule, being onsite 2-3 days a week.
The Clinical Research Manager will lead Clinical Research Scientists to ensure the successful performance and timely delivery of project deliverables with high quality. This role involves overseeing the study program, ensuring compliance, monitoring studies, and identifying risks with appropriate escalation. The manager will drive prioritization within the research program based on strategic direction, track and communicate timelines, risks, and publications, and review program dashboards. Responsibilities include managing assigned study-level execution for pre- and post-market collaborative studies, developing protocols, facilitating cross-functional approvals, and ensuring compliance for data collection and review. The manager will also provide leadership and oversight for the scientific aspects of the program and may manage device ordering, tracking, and accountability of investigational products and trial materials. Additionally, the role involves interfacing with key opinion leaders and external researchers, liaising with regional partners for global standard processes, and serving as a reliable resource for project knowledge.
Healthcare products in pharmaceuticals and devices.
Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.