Clinical Trial Manager

About This Role Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. 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. What You’ll Do Independently or in conjunction with other study Clinical Trial Leads, develop and oversee implementation of the study-level operational strategy for the successful delivery of clinical studies. Chair and Co-Chair the Clinical Study Team (CST) meeting to drive development of scientifically robust, operationally feasible, and clear concepts/protocols. Provide operational guidance to sites, CRO and other key suppliers Provide operational oversight of clinical study suppliers Strategize and coordinate efforts with study start up including site feasibility, site selection, and distribution of regulatory packets Attend scientific meetings Strategize and coordinate efforts to ensure completeness of eTMF Oversee delivery of studies by CROs to ensure quality execution in line with time and budget forecasts. Manage budget, approve invoices and participate in the monthly accrual process Participate in the testing of clinical study systems including IRT and EDC Partner with the CRO SMT lead to ensure the CRO creates appropriate risk-mitigation plans and effectively identifies/resolves issues. Establish and drive efficient team operations by establishing an open culture defined by communication, goal setting, and oversight of strategy implementation. Ensure effective, consistent, efficient and compliant processes. Who You Are Scientifically and clinically astute, you’re a mission-driven individual with the strategic vision to see the big picture and assume responsibilities much broader and more meaningful than day-to-day operations. Decisive, analytical and self-confident, you are determined to own all of your career and the difference you can make on the lives of others through your leadership and ability to inspire excellence.