Senior Clinical Trial Specialist

Annexon Biosciences•Brisbane, CA

3d•$132,000 - $138,700

About The Position

The Senior Clinical Trial Specialist (Sr. CTS) independently coordinates and executes 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 role partners closely with Clinical Trial Managers and cross-functional teams to coordinate study deliverables, support vendor and site activities, maintain study documentation and operational tracking tools, and contribute to inspection readiness.

Requirements

Bachelor’s degree in Life Sciences, Nursing, or a related scientific discipline.
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.
Proficiency with Microsoft Office Suite.
Strong interpersonal, written, and verbal communication skills.
Excellent organizational skills, strong attention to detail, and the ability to manage multiple priorities in a fast-paced environment.
Ability to work as part of a multifunctional, cross-functional study team while independently managing assigned responsibilities.
Based in the San Francisco Bay Area.

Nice To Haves

Experience with eTMF, CTMS, or other clinical systems.

Responsibilities

Independently coordinate and maintain accurate, up-to-date study status information, trackers, and operational metrics for assigned clinical studies.
Develop, maintain, and continuously improve tracking systems, forms, and other documents to support clinical studies.
Prepare and maintain study trackers, spreadsheets, presentations, and other operational documents using 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.
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 and kick-off meetings, including preparing agendas, drafting minutes, tracking action items, and following up on outstanding deliverables.
Assist with tracking clinical lab samples for multiple trials, including shipments from lab vendors, documentation of reconciliation practices, and follow-up on outstanding items.
Support study start-up, maintenance, protocol amendment implementation, and closeout activities as assigned.
Partner with Clinical Supply, Data Management, Regulatory Affairs, Quality Assurance, Medical Monitoring, and other cross-functional teams to support operational study deliverables.
Support departmental process improvement initiatives.