Irvine, California, United States
The candidate must have experience managing company-sponsored clinical trials in accordance with ICH-GCP, applicable legislation, and company SOPs. Responsibilities include overseeing trial conduct from feasibility to closure, managing investigational products, ensuring trial registration and publication support, and collaborating with key opinion leaders, investigators, IRBs/ECs, and regulatory agencies. Experience with clinical data review and potentially monitoring activities is also required.
The Clinical Research Manager will execute and manage company-sponsored clinical trials for JnJ MedTech Electrophysiology, ensuring compliance with timelines and study milestones. This includes oversight of feasibility, selection, setup, conduct, and closure of clinical trials within allocated countries. The role involves managing and tracking investigational products and trial materials, ensuring trial registration and supporting publications, and serving as the team's interface with external stakeholders and company personnel. Additionally, the manager is responsible for clinical data review and may perform monitoring activities. In EMEA, regulatory affairs tasks associated with clinical trials and evidence generation are also included.
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.