Biogen - South San Francisco, CA
posted about 2 months ago
Make the most meaningful impact of your career in this rewarding role with HI-Bio, Inc., a Biogen company. As a Clinical Trial Manager, you will design operational strategy and oversee our clinical research organization (CRO) partners to provide operational input into the development of clear protocol concepts and final protocols. You will own or share responsibility for entire clinical trial studies, including operational design, successful delivery, and the positive impact on the lives of patients with a wide array of immune-mediated diseases. This is a hybrid (part-time on-campus) opportunity, with full-time remote work considered. Independently or in conjunction with other study Clinical Trial Leads, you will develop and oversee the implementation of the study-level operational strategy for the successful delivery of clinical studies. You will chair the Clinical Study Team (CST) meeting to drive the development of scientifically robust, operationally feasible, and clear concepts/protocols. Providing operational guidance to sites, CRO, and other key suppliers will be a key part of your role, as well as overseeing the operational oversight of clinical study suppliers. You will strategize and coordinate efforts with study start-up including site feasibility, site selection, and distribution of regulatory packets, and attend scientific meetings to ensure completeness of eTMF. Your responsibilities will also include overseeing the delivery of studies by CROs to ensure quality execution in line with time and budget forecasts. You will manage the budget, approve invoices, and participate in the monthly accrual process. Additionally, you will participate in the testing of clinical study systems including IRT and EDC, partnering with the CRO SMT lead to ensure the CRO creates appropriate risk-mitigation plans and effectively identifies/resolves issues. Establishing and driving efficient team operations by fostering an open culture defined by communication, goal setting, and oversight of strategy implementation will be essential to your success. You will ensure effective, consistent, efficient, and compliant processes throughout the clinical trial management.