Company:

At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.

For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.

We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture!

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