Clinical Trial Lead - Site & CRA Oversight (Remote)

Alto Neuroscience

Mountain View (CA)

Hybrid

USD 140,000 - 185,000

Full time

5 days ago

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Job summary

Alto Neuroscience is seeking a Clinical Trial Manager to own operational health of investigator sites across studies, ensuring ICH/GCP compliance and protocol adherence. You will lead the CRA study team, drive data quality, and act as the escalation point between field operations and study leadership.

The role requires 10+ years in clinical research, strong monitoring oversight, and hands-on experience with CTMS/eTMF/EDC/eCOA/IRT.

Qualifications

BS/BA in Life Sciences or related field.
10+ years clinical research experience.
3+ years overseeing CRAs or site management staff.
Proficient with CTMS, eTMF, EDC, eCOA and IRT.
Strong knowledge of ICH E6(GCP) and 21 CFR parts.

Responsibilities

Serve as day-to-day operational lead for study CRAs and set monitoring priorities.
Review Monitoring Visit Reports within cycle times and close action items.
Ensure training of CRAs in psychiatry-specific risk areas.
Conduct co-monitoring visits and document coaching outcomes.
Onboard CRAs to protocol and psychiatry, ensure training compliance.
Assist in performance reviews, workload forecasting, and territory coverage.