Manager, Informed Consent Management Oversight Lead
Core
Lead and support cross-functional teams to ensure high-quality, timely delivery of Informed Consent Forms (ICFs) for clinical trials during Study Start Up and Maintenance, ensuring compliance with regulatory requirements.
Role type
Manager, Informed Consent Management Oversight Lead
Builds
Clinical trial study start-up and maintenance processes for Biogen's global portfolio
Domain
Biotechnology / Clinical Operations / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical Operations (Study Delivery/Start Up), GCP, ICH standards, FDA/EMA guidelines, ICF authoring/reviewing, health literacy plain language writing, project management, resource analysis, KPI analysis, SOP maintenance
Preferred skills
eConsent technologies (videos, avatars), IRB/EC negotiation, Veeva proficiency
Responsibilities
Monitor ICF Mailbox and triage incoming requests; Resolve complex ICF issues with legal and pharmacovigilance stakeholders; Provide SME support during study planning and lifecycle oversight; Analyze project requirements to identify resource needs; Author Global Master ICFs; Monitor controlled process documents for compliance; Produce and analyze KPI metrics on compliance and quality; Support cross-functional process improvement initiatives; Maintain Standard Operating Procedures for the IC process
Seniority
Manager, hands-on IC
