Study Start Up CTAU FSP Manager

📋 Description

• • The Study Start Up CTAU FSP Manager role is part of Biogen’s Clinical Trial Accelerator Unit (CTAU) and is critical to driving and managing the FSP insourcing model for Study Start Up (SSU) operations. This role ensures that FSP staffing aligns with business needs, maintains quality and consistency across global clinical trial start-up activities, and supports timely study activation through effective resource planning and oversight.
• • Day-to-day responsibilities include overseeing FSP staff such as Regional Leads, SSU Specialists, and Essential Document Reviewers; serving as the primary point of contact for FSP service providers on resourcing issues; leading resource forecasting and planning to meet business drivers and annual operating plan goals; enabling real-time, agile allocation of EDP reviewers and SSU Specialists for study activations, amendments, and IRB submissions; managing onboarding and offboarding of FSP resources with training and compliance; developing and revising role-specific SOPs to ensure consistency and quality; representing SSU in FSP oversight activities; monitoring and reporting FSP performance; and collaborating with stakeholders to drive continuous improvement.
• • The role sits within Biogen’s CTAU, a specialized unit focused on accelerating clinical trial execution through innovation, efficiency, and strategic partnerships. Biogen is a global biotechnology leader committed to developing life-changing therapies for neurological and neurodegenerative diseases. The company fosters a culture of inclusion, scientific excellence, and patient-centric innovation, offering employees the opportunity to make meaningful contributions in a mission-driven environment.
• • In this role, the individual will develop advanced expertise in global clinical trial start-up operations, FSP vendor management, resource forecasting, and process optimization. They will strengthen leadership and mentoring capabilities while influencing cross-functional alignment across clinical operations, regulatory, and project teams. Success in this position can lead to greater impact in clinical operations strategy and potential advancement into broader operational or functional leadership roles within Biogen’s growing clinical development organization.