Primary RoleThe Rater Oversight Lead owns the operational strategy for protecting primary study endpoints across the portfolio. This role leads rater and rating quality strategies, central rater and eCOA vendor governance, site training, certification, and endpoint-integrity surveillance. Serving as the primary point of contact for endpoint quality, the Rater Oversight Lead collaborates closely with internal teams (CTM, CPM, Clinical Development, Data Management, Biostatistics, Data Science, and QA) and external vendors to safeguard data integrity.
What you'll doRater 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: 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 and/or missed.
Rating Surveillance & Endpoint-Quality Analytics- Partner with data science and 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 with data science on the audio rating-review program: consent compliance, storage and retention, independent reviewer adjudication workflow, and discrepancy resolution between the site rater and central reviewer.
- 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:a rater or site flagged on one study must immediately inform risk visibility for any other active or upcoming study using that same rater or site.
LocationRemote (US)
Salary Range$130,000 - $170,000
*depending on qualifications and experience levelTravel RequiredApproximately 25% travel required (site oversight visits, vendor audits, and investigator meetings)
QualificationsRequired Skills:- 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.
Preferred Skills: - Clinical background as a certified rater, or clinical psychology/psychiatry training - 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.
Supervisory Responsibilities:- Directly governs external central rater vendors and specialty trial contractors; provides dotted-line functional oversight to field CRAs regarding rater quality metrics.
Education and Experience:- BS/BA degree in Life Sciences, Psychology, Neuroscience, or a related field required (Master's or Ph.D. in Clinical Psychology or Neuroscience preferred).
- Minimum of 10 years of progressive clinical trial operations or clinical rating science experience in CNS/psychiatry.
Physical Demands & Work Environment:- Required to sit for prolonged periods of time.
- Hybrid combination of a corporate office environment and remote work; occasional visits to clinical sites or vendor locations with varying noise levels.
