Clinical Outcomes Specialist
Clinical Outcomes Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities
Provide technical expertise in neurocognitive outcomes to support endpoint selection modification or development.
Assess and generate evidence on the psychometric properties clinical meaningfulness and regulatory gaps of neuropsychological outcomes.
Develop and execute operational plans including translation cultural adaptation rater training protocol implementation and trial data monitoring.
Conduct quality monitoring of neuropsychological endpoints including data review for early and latestage studies.
Contribute to the design authoring and review of clinical study protocols and process manuals.
Collaborate crossfunctionally with teams in Clinical Operations Data Management Biometrics Regulatory and Medical Affairs.
- Manage vendors to deliver outcomes aligned with timelines and business objectives.
- Work with clinical trial sites and site raters to ensure proper delivery and collection of trial outcome assessments.
Requirements
Requirements
Advanced degree (Ph.D. strongly preferred) in neuropsychology or a related scientific discipline (e.g. MS MD PharmD PsyD).
Active professional licensure in psychology (or equivalent) preferred.
2 years of experience conducting neuropsychological assessments (postdoctoral experience considered).
2 years of experience in clinical outcomes research within life sciences research organizations academia or governmental agencies.
Expertise in neuropsychological and behavioral assessment development psychometrics and analysis.
Familiarity with outcomes research in pediatric neurodegenerative and/or rare disease therapeutic areas.
Experience training or teaching psychological assessments preferred.
Strong qualitative and quantitative skills in study design data analysis and interpretation.
Employment Type
Full Time
