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 critical for 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 on time and within budget. Additionally, the Senior Clinical Trial Manager will assist in developing processes and infrastructure within clinical operations to enhance 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 facilitating study start-up with CROs and clinical sites, which includes working closely with CROs to complete essential clinical documents such as informed consent forms (ICF), source document worksheets, and clinical site agreements. The Senior Clinical Trial Manager will also organize and run clinical study team meetings and teleconferences, manage study logistics, and monitor activities to ensure that milestones and deliverables are achieved. Recognizing and escalating issues that may jeopardize timelines or lead to out-of-scope expenses is a key responsibility. The role also involves tracking and reporting clinical trial information, conducting monitoring visits, ensuring adherence to documentation requirements, and maintaining clinical trial master files. The Senior Clinical Trial Manager will contribute to the development of clinical project timelines, write or contribute to clinical documents, coordinate the RFP process, and assist in budget development and monitoring. Compliance with federal, state, and local regulations, as well as Good Clinical Practice (GCP) regulations, is essential. The position may also involve mentoring other clinical operations staff and requires travel to domestic and international sites, approximately 30%.