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Salary: USD 140,000 - 185,000 / annual
Alto Neuroscience is seeking a Clinical Trial Manager to own the operational health of investigator sites across one or more clinical studies in precision psychiatry. This role leads the Clinical Research Associate (CRA) team, drives quality and data integrity at site level, and serves as the escalation point between field operations and study leadership.
Key Responsibilities:
CRA Oversight & 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. Review and approve Monitoring Visit Reports within defined timelines, assess findings for adequacy, trend recurring issues, and ensure action items are closed. Ensure CRAs are trained to monitor psychiatry-specific risk areas competently (eligibility diagnosis confirmation, source documentation, rating scale completion, concomitant medication compliance, investigational product accountability). Conduct accompanied/co-monitoring visits to assess CRA performance and protocol comprehension. Onboard CRAs to the protocol and therapeutic area with documented training compliance. Contribute to CRA performance reviews, workload forecasting, and territory planning.
Safety, Quality & Compliance: Ensure site-level execution of suicidal ideation and behavior monitoring per protocol, including scale administration at required timepoints and escalation pathways. Verify sites maintain documented arrangements for managing acute clinical deterioration. Oversee site-level investigational product handling, blinding integrity, storage, dispensing accuracy, and reconciliation. Execute the study-level Risk-Based Quality Management plan at site level, monitoring Key Risk Indicators and Quality Tolerance Limits. Ensure timely identification and escalation of protocol deviations, informed consent issues, and potential serious breaches. Partner with Data Management to drive data entry and query resolution timelines. Support site-level eCOA/ePRO execution and Trial Master File completeness. Support audit and inspection readiness.
Clinical Supplies & Vendor Interface: Coordinate site-level investigational product logistics (resupply, expiry, accountability, reconciliation, destruction). Serve as site-facing point of contact for specialty vendors; troubleshoot site-level issues and escalate systemic problems. Support investigator payment triggers and queries.
Documentation & Systems: Contribute to Monitoring Plan, Site Management Plan, source templates, informed consent template, and training materials. Maintain accuracy of CTMS, eTMF, and tracking systems as primary system-of-record owner for site-level data. Provide site-level status reporting and metrics to study team meetings and governance forums.
Travel: Approximately 25–30% required.
Requirements:
Required:
- BS or BA in Life Sciences or related field
- 10+ years clinical research experience within biotech, pharma, or CRO, including 3+ years direct monitoring experience as a CRA
- 4+ years managing, mentoring, or providing oversight of CRAs or site management staff, including Monitoring Visit Report 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:
- Direct experience in an insourced/sponsor-monitored model where the sponsor holds monitoring accountability without CRO intermediation
- Experience across multiple psychiatric indications 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
- Experience with RBQM/KRI frameworks and centralized monitoring analytics
- Prior participation in FDA, EMA, or MHRA inspection or sponsor audit of a clinical site
- Line-management experience (hiring, performance management, development planning)
