About Alto Neuroscience, Inc. At Alto Neuroscience, you will play a pivotal role in advancing precision psychiatry and improving how mental health disorders are treated. Join us in building the next generation of personalized neuroscience-based therapeutics. Backed by Stanford.
About the role
Alto Neuroscience is an equal-opportunity employer that does not discriminate on the basis of sex, age, race, color, religion, marital status, sexual orientation, gender identity, pregnancy, disability, or any other characteristic protected by law. We offer a welcoming and inclusive environment in service to one another, our products, the diverse consumers we represent, and the communities we call home. We do all of this with kindness, empathy and respect for each other.
What they're looking for
- BS, BA in Life Sciences or related field
- 10+ years clinical research within biotech, pharma, or a CRO, including meaningful direct monitoring experience (i.e., 3+ years as a CRA)
- 4+ years managing, mentoring, or providing oversight of CRAs or site management staff, including MVR review
- Working command of ICH E6(R3) GCP, 21 CFR Parts 11/50/54/56/312, EU CTR 536/2014 as applicable, and applicable regional requirements
- Demonstrated ability to diagnose and remediate underperforming sites, not simply report on them
- Hands-on proficiency with CTMS, eTMF, EDC, eCOA, and IRT systems
More about this role
Primary Role
- The Clinical Trial Manager owns the operational health of the investigator sites assigned to one or more studies ensuring compliance with SOPs, ICH/GCP guidelines, and protocol requirements. They lead the CRA study team, drives signal-detection quality and data currency at site level, and serves as the escalation point between the field and the study leadership team.
- Success in this role is measured in site performance: sites activated on time, enrolling to plan, monitored on schedule, rating reliably, with clean data and no repeat findings.
What you'll do
CRA Oversight and Field Team Leadership
- Serve as the day-to-day operational lead for study assigned CRAs; set monitoring priorities, balance site loads, and manage visit scheduling against the Monitoring Plan.
- Review and approve Monitoring Visit Reports (MVRs) within defined cycle times; assess findings for adequacy, trend recurring issues across the CRA team, and ensure action items are closed rather than merely documented.
- Ensure CRAs are trained to monitor psychiatry-specific risk areas competently (in partnership with the Head of Clinical Monitoring): eligibility diagnosis confirmation, source...
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