Senior Clinical Trial Specialist

Summary

Join Biogen's West Coast Hub in South San Francisco as a Clinical Trial Specialist (CTS) or Senior CTS and contribute to the execution of clinical trials. You will support the conduct of clinical trials, ensuring alignment with GCP and Biogen's SOPs. The role involves managing multiple priorities, meeting quality standards, and collaborating with various teams. You will help define aspects of clinical trials to ensure timely completion, efficient protocols, budget alignment, and compliance. The position reports to the Head of Development Operations, and the level will depend on experience. This role offers the opportunity to work remotely within the United States.

Requirements

• Combination of degree and relevant Biopharma related experience within a pharmaceutical, biotech environment in a Clinical Operations function/role
• Bachelor’s degree and 3 years of direct related experience
• OR Associates degree and 5 years of direct related experience
• OR High school diploma or equivalent and 6 years of direct related experience
• Ability to manage multiple priorities and allocate tasks efficiently to keep trials on track
• Current knowledge of ICH, GCP, and other regulatory guidelines
• Ability to think critically and solve problems, possesses a quick and analytical mind, is a fast‑learner and works well in an organization that places a high value on intellectual capacity
• Strong attention to detail and an ability to identify gaps and innovate solutions
• Excellent written and verbal communication and a highly motivated disposition

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

Preferred Qualifications

Experience in a small company or immunology is a plus

Benefits

• Medical, dental, life, long and short-term disability insurances
• Vacation
• End-of-year shutdown
• 401K participation and matching contributions
• Biogen’s LTI grants and other incentive programs
• Remote work