Position: The Senior Clinical Trial Specialist (Sr. CTS) is responsible for independently coordinating and executing operational activities across one or more clinical studies from study start-up through closeout under the direction of, or as delegated by, the Global Clinical Operations team. The Sr. CTS partners closely with Clinical Trial Managers and cross-functional teams to coordinate assigned study deliverables, support vendor and site activities, maintain study documentation and operational tracking tools, and contribute to inspection readiness.
Responsibilities include:- Independently coordinate and maintain accurate and up-to-date study status information, trackers, and operational metrics for assigned clinical studies
- Develop, maintain, and continuously improve tracking systems, forms, and other relevant documents to support clinical studies
- Prepare and maintain study trackers, spreadsheets, presentations, and other operational documents utilizing Microsoft Office Suite
- Perform routine quality reviews of the eTMF to ensure completeness, accuracy, and ongoing inspection readiness
- Maintain and organize electronic clinical trial documents and ensure timely filing of essential documents in the eTMF for ongoing projects
- Coordinate collection, review, and tracking of essential study documents from study sites, CROs, and vendors to support study milestones and inspection readiness
- Coordinate logistics for clinical operations team meetings, kick-off meetings, etc., preparing agendas, drafting meeting minutes, tracking action items, and following up on outstanding deliverables
- Assist in the tracking of clinical lab samples for multiple clinical trials, including tracking shipments of samples from lab vendors and helping maintain documentation of reconciliation practices and follow up any outstanding items
- Support study start-up, maintenance, protocol amendment implementation, and study closeout activities, as assigned
- Partner with cross-functional teams, including Clinical Supply, Data Management, Regulatory Affairs, Quality Assurance, and Medical Monitoring to support operational study deliverables
- Support departmental process improvement initiatives
Education, Experience, and Skills: Required: - Bachelor's degree in Life Sciences, Nursing, or a related scientific discipline required
- Minimum of 4-6 years of experience supporting clinical trials in the biotechnology, pharmaceutical, or CRO industry, with demonstrated experience coordinating multiple clinical studies
- Working knowledge of ICH GCPs and applicable international regulations governing clinical research
- Proficient with MS Office Suite; experience with eTMF, CTMS, or other clinical systems preferred
- Strong interpersonal, written, and verbal communication skills
- Excellent organizational skills with strong attention to detail and the 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
Salary Range: $132,000 - $138,700 Location: Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area.
Benefits: - A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
- Shuttle service from BART, CalTrain and the Ferry.
- Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits.
