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.
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 documentation supporting subjective ratings, CHRT-SR/CHRT-C completion and follow-through, rating window adherence, concomitant psychotropic and washout compliance, and IP accountability and reconciliation.
- Conduct accompanied/co-monitoring and oversight visits to assess CRA performance, protocol comprehension, and consistency of monitoring practice. Work collaboratively with the Head of Clinical Monitoring to document coaching outcomes and assess individual development plans.
- Onboard CRAs to the protocol and to psychiatry as a therapeutic area; deliver study-specific training and ensure documented training compliance before independent site activity.
- Contribute to CRA performance reviews, workload forecasting, and territory/regional coverage planning; identify capacity gaps early enough to act on them.
Safety, Quality, and Compliance
- Ensure site-level execution of suicidal ideation and behavior monitoring per protocol (e.g., CHRT-SR/C), including that scale administration occurs at required timepoints, that protocol-defined thresholds trigger the required clinical actions, and that escalation, unblinding-if-required, and safety reporting pathways are followed and documented.
- Verify that sites maintain documented, workable arrangements for managing acute clinical deterioration — access to a treating clinician, hospitalization pathway, and after-hours coverage — and escalate deficiencies immediately.
- Oversee site-level IP handling and blinding integrity: storage conditions, dispensing accuracy, accountability records, and reconciliation discrepancies — including any site practice that risks compromising the blind.
- Execute the study-level Risk-Based Quality Management (RBQM) plan at site level: monitor Key Risk Indicators (KRIs) and Quality Tolerance Limit (QTL) signals, investigate excursions, and implement mitigations.
- Ensure timely, accurate identification, documentation, and escalation of protocol deviations, informed consent issues (including capacity-to-consent and, where applicable, legally authorized representative processes), and potential serious breaches or research misconduct.
- Partner with Data Management to drive data entry and query resolution timelines in support of interim analyses, DSMB/DMC meetings, and database lock
- Partner with the Rater Oversight Lead to support site-level eCOA/ePRO execution: device provisioning, subject training, compliance monitoring, and troubleshooting non-compliance patterns that threaten endpoint completeness.
- Maintain site-level Trial Master File (TMF) completeness and quality in real time — not retrospectively; support TMF reviews and remediation.
- Support site-level inspection and audit readiness: participate in mock inspections, prepare sites for audits, and own CAPA execution for site- and monitoring-related findings.
Clinical Supplies and Vendor Interface at Site Level
- Coordinate site-level IP/IMP logistics: resupply triggers, expiry and re-labeling, accountability and reconciliation, and destruction authorization.
- Serve as the site-facing point of contact for specialty vendors; troubleshoot site-level vendor issues and escalate systemic vendor problems to the CPM/Study Delivery Lead.
- Support site-level payment triggers and investigator payment queries in partnership with Finance/Contracts.
Documentation and Systems
- Contribute to the Monitoring Plan, Site Management Plan, source templates, informed consent template, rater and site training materials, and study-specific tools.
- Maintain accuracy of CTMS, eTMF, and tracking systems as the primary system-of-record owner for site-level data.
- Provide site-level status reporting and metrics into study team meetings and governance forums.
Location
Onsite- Mountain View, CA *will consider Remote
Salary Range
$140,000 - $185,000
*depending on qualifications and experience level
Travel Required
Approximately 25–30%
Qualifications
Required Skills:
- 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.
Preferred Skills:
- Direct experience in an insourced/sponsor-monitored model, where the sponsor holds monitoring accountability without CRO intermediation.
- Experience across more than one psychiatric indication with outpatient and/or inpatient/partially-inpatient study designs.
- Familiarity with placebo-response mitigation strategies, central/remote independent rating, dual-rater designs, and SAFER-type interview practices.
- Experience with duplicate-subject and professional-subject detection services and the site dynamics that make them necessary.
- Experience with RBQM/KRI frameworks and centralized monitoring analytics.
- Prior participation in an FDA, EMA, or MHRA inspection or a sponsor audit of a clinical site.
- Line-management experience (hiring, performance management, development planning).
Physical Demands & Work Environment:
- Required to sit for prolonged periods of time.
- While performing the duties of this job, the noise level in the work environment is usually quiet.
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. The above is intended to describe the general content of and requirements for the performance of this job. It should not be construed as an exhaustive statement of duties, responsibilities or physical requirements.
