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Salary: USD 115,000 - 130,000 / annual
MapLight Therapeutics is a clinical-stage biotech company focused on drug discovery for central nervous system disorders, combining optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop therapies for psychiatric symptoms.
The Senior Clinical Trial Associate will support Clinical Operations and project teams across all phases of clinical projects. This role requires adaptability, ownership of tasks, problem-solving, and the ability to see activities through to completion.
Key responsibilities include:
- Interact directly with Clinical Research Associates (CRAs), trial managers, site staff, and vendors (U.S. and worldwide) to provide support in project-specific tasks and overall clinical trial management
- Maintain and manage user access requests and deactivation for study systems
- Coordinate materials (presentations, templates, essential document listings) for internal and external meetings
- Distribute safety alerts and relevant documents as required
- Maintain and update study team and vendor contact information
- Assist in planning, organizing, and executing study-specific meetings; write and distribute agendas, minutes, and updates
- Participate in reviewing, formatting, and finalizing study-related templates, plans, and manuals
- Assist with maintaining clinical trial insurance
- Route questions, issues, and requests from the Clinical Research Organization (CRO) to appropriate team members
- Participate in clinical data review as needed
- Ensure completeness of documents in Trial Master Files (TMF); perform ongoing reviews for quality and compliance with SOPs and ICH GCP Guidelines
- Route, track, and file clinical documents; conduct initial and ongoing reviews of site regulatory documentation
- Develop and maintain study-related trackers to support Clinical Operations; analyze and update associated data
- Support Study Team Leads and Operational Team Leads with additional duties as assigned
Travel: Up to 35% travel required.
Qualifications:
- Bachelor's degree in a relevant subject area highly recommended, or combination of education and applicable job experience
- Minimum 2+ years in biotech, pharmaceutical industry, or clinical trial management
- Competency in drug development process with knowledge of ICH-GCP is a plus
- Strong interpersonal, organizational, and planning skills with excellent verbal and written communication
- Proactive self-starter with ability to take responsibility for tasks and execute seamlessly; ability to identify efficiency improvements across studies
