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Salary: USD 130,000 - 170,000 / annual
Alto Neuroscience is seeking a Rater Oversight Lead to own the operational strategy for protecting primary study endpoints across their clinical trial portfolio. This role is central to safeguarding data integrity in CNS/psychiatry trials through comprehensive rater and rating quality management.
Key Responsibilities:
Rater Qualification, Certification & Training: Own the portfolio-wide rater qualification and certification model, setting criteria, ongoing training requirements, and recertification cadences. Track rater continuity at investigator sites, proactively identifying and mitigating turnover risks before data quality is impacted. Partner with Clinical Development and Biostatistics during protocol design to select optimal rating methodologies (central vs. site-based, dual-rater, independent review) and translate them into executable programs.
Central Rater Vendor Governance: Govern the central rater-training and rating-surveillance vendor(s) portfolio-wide. Responsible for vendor performance governance including training-completion turnaround, certification-issuance SLAs, session/recording review turnaround, and audit-trail completeness for inspection readiness. Conduct routine vendor quality reviews and scorecards; issue corrective action requests when SLAs or quality standards are at risk or missed.
Rating Surveillance & Endpoint-Quality Analytics: Partner with data science to assess inter-rater reliability (IRR) tracking, score-distribution analysis by site and rater, baseline severity drift monitoring, and eCOA compliance surveillance across every active study. Collaborate on the audio rating-review program including consent compliance, storage and retention, independent reviewer adjudication workflow, and discrepancy resolution. Drive site- and rater-level intervention—retraining, heightened monitoring, restriction, or exclusion—based on analytics, early enough in a study's enrollment that intervention still changes the outcome. Maintain a portfolio-wide rater/site risk registry so that a rater or site flagged on one study immediately informs risk visibility for any other active or upcoming study using that same rater or site.
Supervision: Directly governs external central rater vendors and specialty trial contractors; provides dotted-line functional oversight to field CRAs regarding rater quality metrics.
The role requires approximately 25% travel for site oversight visits, vendor audits, and investigator meetings.
Requirements:
Required: 10+ years of experience in clinical rating science, clinical outcome assessment (COA), or endpoint quality roles within CNS/psychiatry trials. Direct experience managing or governing central rater-training and rating-surveillance vendors across multi-study or portfolio-level programs. Statistical literacy sufficient to interpret IRR, score distributions, and data surveillance analytics alongside Biostatistics. Proven ability to enforce tough operational decisions (e.g., restricting or excluding high-enrolling site raters) under timeline and site-relationship pressure. BS/BA degree in Life Sciences, Psychology, Neuroscience, or a related field required.
Preferred: Clinical background as a certified rater, or clinical psychology/psychiatry training for credibility with sites and raters when making restriction/exclusion calls. Experience running surveillance across multiple concurrent studies rather than one at a time. Experience with video/audio rating-review adjudication workflows. Master's or Ph.D. in Clinical Psychology or Neuroscience.
