Coherus Biosciences - Redwood City, CA
posted about 2 months ago
The Senior Clinical Trial Manager will play a pivotal role in the Coherus clinical team, overseeing the execution of clinical studies for various products. This position is designed for individuals with a strong background in clinical operations, particularly in managing complex Phase 1 studies, global Phase 2-3 studies, and post-marketing commitment studies. Depending on the complexity of the projects and the level of experience, the Senior Clinical Trial Manager may be responsible for managing one or more clinical studies or overseeing a multi-national region for multiple global clinical studies. The role involves close collaboration with contract research organizations (CROs), clinical laboratories, and other vendors, including clinical sites, to ensure that clinical studies are conducted efficiently, on time, and within budget. Additionally, the Senior Clinical Trial Manager will assist in developing processes and infrastructure within clinical operations to enhance overall efficiency and effectiveness. In this role, the Senior Clinical Trial Manager will act as the primary liaison to CROs and vendors for assigned clinical studies, ensuring adherence to project scope, deliverables, and timelines. The position requires organizing and facilitating study start-up activities, including the completion of essential clinical documents and agreements. The Senior Clinical Trial Manager will also be responsible for managing study logistics and monitoring activities, tracking clinical trial information, and reporting on patient recruitment and data cleaning status. The role may involve conducting monitoring visits and ensuring compliance with documentation requirements and Good Clinical Practice (GCP) regulations. Furthermore, the Senior Clinical Trial Manager will contribute to the development of clinical project timelines, clinical documents, and budgets, while also mentoring other clinical operations staff as needed.