Clinical Trial Specialist

Summary

Join us on our journey to transform lives of patients with severe immune-mediated diseases as a Clinical Trial Specialist (CTS) or Senior CTS, supporting clinical trials execution and ensuring alignment with GCP and Biogen's SOPs.

Responsibilities

• Overall global tracking of study deliverables with escalation of key issues/trends
• Support and/or manage protocol related site/supplier activities
• Assist and/or manage in the design, format, review and content of study guides, worksheets, quick reference cards and other materials/documents used to support the study
• Contribute to protocol review and amendment management, including informed consent initiation and updates
• Attend, contribute and potentially lead supplier meetings; work with suppliers to resolve issues, and foster process improvements
• Monitor progress of studies, help identify study related trends/issues and work with Clinical Trial Managers (CTM) to implement corrective actions when necessary
• Submission of documents to TMF and assist with TMF reconciliation as needed
• Oversee study start-up activity tracking with CTM oversight
• Assist tracking study milestones in tools and dashboards
• Point of contact (as delegated) for study related issues
• Contribute to the development of recruitment strategies and materials; assist with external recruitment activities and supplier management
• Work with sample management to coordinate shipment and analysis of sample needs; lead reconciliation efforts
• Support and contribute to Inspection Readiness processes
• May participate in cross-functional study management activities and process improvement initiatives
• Lead Site Management Oversight tasks to ensure CRO activities are being completed per the Monitoring Plan
• Contribute to protocol review, content and ICF development