Senior Clinical Trial Specialist

The role

The Senior Clinical Trial Specialist coordinates and executes operational activities for one or more clinical studies from start-up through closeout. This role partners with Clinical Trial Managers and cross-functional teams to support vendor and site activities and maintain study documentation.

What you will do

• Coordinate and maintain study status information, trackers, and operational metrics
• Develop and improve tracking systems, forms, and relevant documents
• Prepare study trackers, spreadsheets, presentations, and operational documents using Microsoft Office Suite
• Perform routine quality reviews of the eTMF
• Maintain and organize electronic clinical trial documents in the eTMF
• Coordinate collection, review, and tracking of essential study documents from sites, CROs, and vendors
• Coordinate logistics for clinical operations team meetings and prepare agendas, minutes, and action items
• Assist in tracking clinical lab samples and shipments from lab vendors
• Support study start-up, maintenance, protocol amendment implementation, and study closeout
• Partner with cross-functional teams to support operational study deliverables

Required qualifications

• Bachelor’s degree in Life Sciences, Nursing, or a related scientific discipline
• Minimum of 4-6 years of experience supporting clinical trials in the biotechnology, pharmaceutical, or CRO industry
• Demonstrated experience coordinating multiple clinical studies
• Working knowledge of ICH GCPs and applicable international regulations governing clinical research
• Proficient with MS Office Suite
• Strong interpersonal, written, and verbal communication skills
• Excellent organizational skills with strong attention to detail
• Ability to manage multiple priorities in a fast-paced environment
• Ability to work as part of a multi-functional, cross-functional study team while independently managing assigned responsibilities
• Based in the San Francisco Bay Area

Nice to have

• experience with eTMF, CTMS, or other clinical systems

Benefits

• Flexible work schedules
• Remote opportunities
• Ability to achieve a work-life balance
• Shuttle service from BART, CalTrain and the Ferry
• Competitive base salary
• Equity participation
• Employee stock purchase plan
• Medical
• Dental
• Vision
• 401(k)
• Flexible spending plans

About the company

Annexon Biosciences is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for neuroinflammatory diseases. The company is headquartered in Brisbane, CA.