Bachelor's degree in Life Sciences, Nursing, or related field required
4-6 years of experience in clinical trials within biotech, pharmaceutical, or CRO sectors
Knowledge of ICH GCPs and international clinical research regulations
Proficient in MS Office Suite; familiarity with eTMF and CTMS preferred
Strong communication skills, both written and verbal
Excellent organizational skills with attention to detail
Ability to work independently and as part of a cross-functional team
Located in the San Francisco Bay Area
Responsibilities
Independently coordinate and maintain study status information and operational metrics
Develop and improve tracking systems and relevant documents for clinical studies
Prepare and maintain operational documents using Microsoft Office Suite
Conduct quality reviews of the eTMF for completeness and inspection readiness
Organize electronic clinical trial documents and ensure timely filing in the eTMF
Coordinate collection and review of essential study documents from sites and vendors
Manage logistics for clinical operations meetings, including agendas and action items
Assist in tracking clinical lab samples and maintaining documentation for trials
Support study start-up, maintenance, and closeout activities as assigned
Collaborate with cross-functional teams to support operational deliverables
Contribute to departmental process improvement initiatives
Benefits
Flexible work schedules and remote opportunities for work-life balance
Shuttle service from BART, CalTrain, and the Ferry
Competitive base salary and equity participation
Employee stock purchase plan
Comprehensive health benefits including medical, dental, and vision
401(k) and flexible spending plans
Full Job Description
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.
About Annexon Biosciences
Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, eye and brain. The company's pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is advancing a portfolio of product candidates into clinical development, including its lead program, ANX005, for the treatment of Guillain-Barré Syndrome and Warm Autoimmune Hemolytic Anemia. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated exposure level, enabling the company to continue development with a high level of confidence in its approach.
