Oversee the scientific delivery of psychiatry clinical trial services across a portfolio of studies, including rater training and central monitoring.
Contribute to definition and implementation of study-specific delivery plans for endpoint quality, including integration of central monitoring and review workflows.
Provide direction to internal study teams on feasibility, scale selection, administration standards, and timing of deliverables.
Serve as the primary scientific point of contact for assigned studies, ensuring clarity and consistency in internal and sponsor communications.
Contribute to design and implementation of rater training programs (e.g., MADRS, HAM-D, HAM-A, YMRS), including certification, calibration, and remediation pathways.
Monitor central monitoring outputs, including identification of data quality signals, rater drift, and protocol deviations, and guide appropriate follow-up actions.
Support the resolution of scientific and data quality escalations arising from central monitoring and study review activities.
Develop central monitoring resources to systematize feedback.
Collaborate with Project Management to ensure efficient and profitable delivery of services, including resource allocation and workflow optimization.
Contribute to the development and standardization of SOPs, training materials, and operational guidelines for psychiatry trials.
Support staff development within scientific and rater training teams, including mentoring and performance feedback.
Contribute to the development and refinement of psychiatry-focused products and services, including rater training programs, central monitoring methodologies, and scale-specific guidance.
Support innovation in endpoint quality assurance and approaches for detecting data quality issues.
Contribute to the design and interpretation of metrics related to rater performance, endpoint reliability, and data quality.
Analyze patterns in clinical trial data to identify risks such as placebo response inflation, rater drift, and scoring inconsistencies.
Provide scientific consultation on study design, scale selection, administration strategy, and risk mitigation.
Support business development through scientific input in proposals
Drive scientific dissemination through publications, conference presentations, and internal knowledge-sharing initiatives.
Contribute to advancing best practices in psychiatric endpoint assessment and central monitoring.
Requirements
Tertiary qualifications or post graduate degree in the area of psychology, psychiatry, neuroscience, or related field
Evidence of scientific track record in publications, conference presentations, patents or grants, with maintenance of on-going professional development.
Experience in interacting with clinical scientists, neuropsychologists and medical professionals at a high level.
Experience managing scientific projects and directing staff.
At least 6 years of neuropsychological practical experience.
An understanding of the science of measuring cognition and behavior, including an understanding of computer-based tools and traditional neuropsychological assessment tools available to measure change in cognition in a clinical setting
Expertise in psychiatric rating scales (e.g., MADRS, PANSS, HAM-D, YMRS) and structured interview methodologies (e.g., SIGMA).
Experience with rater training, central monitoring, or data quality oversight.
5+ years of experience in clinical trials, with emphasis on CNS/psychiatry preferred.
Benefits
Remote Work Practices: Cogstate is a virtual first company. Cogstate employees can work from anywhere where Cogstate is registered to business within the United States, Australia, or the United Kingdom!
Generous Paid Time-off: Cogstate employees receive 20 days of vacation leave, 10 days of personal leave and 10 paid public holidays.
401(k) Matching: As you invest in yourself and your future, Cogstate invests in you too: we match up to3% of your yearly salary in Cogstate’s 401k program.
Competitive Salary: We offer competitive base salaries plus additional earning opportunities based on the position.
Health, Dental & Vision Coverage: We've invested in comprehensive health & dental insurance options with competitive company contributions to help when you need it most. We also offer free vision insurance for all full-time employees.
Short-Term & Long Term Disability Life Insurance: 100% employer sponsored
Pre-Tax Benefits: Healthcare and Dependent Care Flexible Spending Accounts
Learning & Development Opportunities: Cogstate offers a robust learning program from mentorships to assistance with programs to improve knowledge or obtain certifications in applicable areas of interest.