Summary

The Senior Manager, Clinical Operations provides line management and functional oversight for a team of clinical trial staff spanning Clinical Trial Associate (CTA), Clinical Research Associate (CRA), Clinical Trial Manager (CTM), and Clinical Project Manager (CPM) levels. Trials are run in-house rather than outsourced to a CRO, so this role and its team hold direct, hands-on responsibility for site management, monitoring, and trial execution rather than oversight of a CRO's delivery. This role is responsible for staff development, workload/resource allocation across assigned studies or programs, and ensuring consistent quality and process adherence across the team, while individual contributors retain day-to-day accountability for their assigned trials.

Job description

Primary Role

The Senior Manager, Clinical Operations provides line management and functional oversight for a team of clinical trial staff spanning Clinical Trial Associate (CTA), Clinical Research Associate (CRA), Clinical Trial Manager (CTM), and Clinical Project Manager (CPM) levels. Trials are run in-house rather than outsourced to a CRO, so this role and its team hold direct, hands-on responsibility for site management, monitoring, and trial execution rather than oversight of a CRO's delivery. This role is responsible for staff development, workload/resource allocation across assigned studies or programs, and ensuring consistent quality and process adherence across the team, while individual contributors retain day-to-day accountability for their assigned trials.

What you'll do

People Management

Directly manage, coach, and develop a team of 6–12 clinical staff across CTA, CRA, CTM, and CPM levels
Conduct performance reviews, goal setting, and career development planning tailored to each direct report's role and level
Lead recruitment, onboarding, and training for new team members
Identify training needs and coordinate role-specific development (e.g., TMF management for CTAs, site monitoring for CRAs, vendor oversight for CTMs, cross-functional leadership for CPMs)

Resource & Workload Management

Allocate staff across studies based on trial phase, complexity, and enrollment status
Monitor team capacity and escalate resourcing gaps or overallocation to the Director/Senior Director
Support study budgeting and FTE planning in partnership with Clinical Operations leadership

Operational & Quality Oversight

Ensure team members follow ICH-GCP, SOPs, and applicable regulatory requirements across assigned trials
Review and approve key study deliverables (monitoring plans, TMF completeness, site management plans) as appropriate to level
Provide direct, hands-on guidance on site selection, initiation, monitoring, and close-out — activities performed in-house by the team's CRAs and CTMs rather than a CRO
Serve as an escalation point for site-level or protocol-execution issues that direct reports cannot resolve independently
Partner with QA on audit/inspection readiness and CAPA follow-up for the team's studies

Cross-Functional Collaboration

Represent Clinical Operations staffing and capacity needs in program-level planning meetings
Partner with Clinical Development, Regulatory, Biostatistics, and Data Management leads to align trial execution with program timelines
Provide input to senior leadership on process improvements and standardization across trials

Location

Mountain View, CA or Remote (US)

Travel Required

Travel required (approximately 25–30%)

Requirements

10+ years of hands-on clinical trial experience across multiple Clinical Operations roles, including CTA, CRA, CTM, and/or CPM experience
3+ years of direct people management experience
Direct experience with site monitoring, site management, and clinical trial execution in an in-house operating model
Strong working knowledge of ICH-GCP, FDA/EMA regulations, and the clinical trial lifecycle
Demonstrated experience managing and developing Clinical Operations staff across varying levels of seniority
Strong organizational, communication, and problem-solving skills, with the ability to manage competing priorities across multiple studies
Experience with inspection readiness, audits, and CAPA follow-up
Experience supporting multiple clinical programs or studies simultaneously
Bachelor's degree in life sciences, nursing, or related field
Experience building or improving Clinical Operations processes, tools, and ways of working in a growing biotech environment

Company overview

Alto Neuroscience is a clinical-stage biotechnology company pioneering precision psychiatry by developing biology-driven medicines for neuropsychiatric conditions. Founded in 2019 by Dr. Amit Etkin, a former Stanford professor, the company leverages 15 years of field-leading neuroscience research to transform the trial-and-error approach to psychiatric treatment. Alto's innovative Precision Psychiatry Platform™ utilizes AI-derived brain biomarkers, including EEG data, wearable metrics, behavioral patterns, and genetic factors, to match patients with the most effective treatments. The company's clinical-stage drug candidates target core brain processes in major depressive disorder, bipolar depression, and schizophrenia, with the goal of helping patients get better faster through personalized therapeutic solutions. Based in Mountain View, California, Alto Neuroscience represents a new paradigm in mental health treatment, combining deep neurobiological insights with advanced data analytics to deliver targeted, effective medicines for neuropsychiatric disorders.