Manager, Informed Consent Management Oversight Lead

Lead and operationalize Biogen's Informed Consent Management (ICM) initiatives across global clinical trials, overseeing processes to ensure High-quality informed consent forms (ICFs) are delivered on time to meet study milestones. Manage cross-functional teams, liaise with IRBs/ECs, resolve complex ICF issues, and provide SME support during study start-up and lifecycle management. Oversee CRO partnerships to ensure compliant consent, contribute to protocol authoring when needed, monitor KPI metrics for compliance and quality, drive process improvements, maintain SOPs/WIs, and ensure alignment with regulatory requirements (GCP, ICH, FDA/EMA). Strong project management, stakeholder engagement, and health-literacy focused writing are required; experience with eConsent and Veeva is preferred. The role is based in Cambridge, MA, with senior-level responsibilities in a global organization.