Senior Clinical Trial Specialist

Summary

Join Biogen's West Coast Hub in South San Francisco as a Senior Clinical Trial Specialist (CTS) and contribute to the development of novel targeted therapies for patients with severe immune-mediated diseases. You will support the execution of clinical trials, ensuring alignment with GCP and Biogen's SOPs, and provide administrative, coordination, and organizational support to the Clinical Study Lead and team members. This role requires strong organizational skills, attention to detail, and the ability to manage multiple priorities. You will also contribute to protocol review, amendment management, and the development of recruitment strategies and materials. This position is open to remote talent in 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, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation