Remote Clinical Trial Operations Lead — Psychiatry

Alto Neuroscience; Mountain View (CA); On-site; USD 140,000 - 185,000; Full time

Job summary

Alto Neuroscience, Mountain View, CA is seeking a seasoned Clinical Trial Manager to own the operational health of investigator sites across studies. You will lead CRA teams, ensure adherence to SOPs/ICH-GCP, and drive data quality and site performance from activation to completion.

You will collaborate with the Head of Clinical Monitoring to train CRAs, oversee risk-based monitoring, and support TMF readiness while advancing psychiatry-focused trials.

Qualifications

• 10+ years clinical research experience in biotech, pharma, or CRO
• 3+ years of direct CRA oversight/mentoring experience
• Strong knowledge of ICH E6(R3) GCP and applicable regulations

Responsibilities

• Serve as day-to-day operational lead for study CRAs; set monitoring priorities and manage visit scheduling
• Review Monitoring Visit Reports and ensure timely closure of action items
• Ensure CRA training on psychiatry-specific risk areas and protocol adherence
• Conduct co-monitoring visits and document coaching outcomes with the Head of Clinical Monitoring
• Onboard CRAs to protocols and psychiatry as a therapeutic area and deliver site-specific training
• Contribute to CRA performance reviews, capacity planning, and territory coverage

Skills

Clinical research experience

CRA oversight

Leadership and mentoring

ICH E6(R3) GCP knowledge

Cross-functional collaboration

CTMS/eTMF/EDC/eCOA/IRT proficiency

Education

BS/BA in Life Sciences

Tools

CTMS

eTMF

EDC

eCOA

IRT

Job description

Alto Neuroscience, Mountain View, CA is seeking a seasoned Clinical Trial Manager to own the operational health of investigator sites across studies. You will lead CRA teams, ensure adherence to SOPs/ICH-GCP, and drive data quality and site performance from activation to completion.

You will collaborate with the Head of Clinical Monitoring to train CRAs, oversee risk-based monitoring, and support TMF readiness while advancing psychiatry-focused trials.