About this opportunity
Alphanumeric Systems Inc lists this Clinical Outcome Assessments Manager opportunity in durham, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Now Hiring: Clinical Outcome Assessments Manager - ViiV Healthcare
Durham, NC | Remote or Onsite
Normal Business Hours / Core Hours
Hourly Pay: $50.00 - 54.00
I'm recruiting for aClinical Outcome Assessments (COA) Manager to support theViiV Healthcare Global Health Outcomes team .
This is a scientific, measurement-focused role supporting ViiV's drug development portfolio acrossHIV treatment and prevention . The successful candidate will contribute to the development, validation, and implementation ofClinical Outcome Assessment instruments and patient-centered endpoints used in clinical trials and observational studies.
This is an excellent opportunity for someone with a background inCOA, patient-reported outcomes (PRO), psychometrics, health outcomes research, or measurement science who enjoys working at the intersection of patient experience, clinical development, and regulatory strategy.
Key areas of responsibility include:
Supporting the design and execution of COA development and validation studies , including patient-experience data collection and analysis.
Selecting, adapting, developing, validating, and implementing COA instruments for clinical trials and observational research.
Applying qualitative research methods, psychometric principles, and statistical approaches to evaluate measurement properties.
Supporting FDA and other health authority interactions related to COA and patient-centered endpoint strategies.
Contributing to briefing documents, regulatory submissions, endpoint rationale, protocols, SAP language, and responses to health authority questions.
Partnering cross-functionally with Biostatistics, Regulatory Affairs, Medical Affairs, Clinical Development, R&D, and Clinical Operations.
Supporting publications, conference presentations, and other external scientific activities.
Helping advance measurement-science standards and COA best practices across the portfolio.
Required qualifications:
Bachelor's degree in psychometrics, health outcomes research, epidemiology, biostatistics, public health, behavioral science, biomedical engineering, data science, or a related discipline.
3+ years of relevant experience within pharmaceutical, biotechnology, digital health, CRO, or academic environments.
Demonstrated experience with Clinical Outcome Assessments, patient-centered outcomes, or related measurement science.
Experience contributing to the development, validation, or implementation of COA instruments or digital measures in clinical trials.
Familiarity with statistical approaches used for COA/digital endpoints, including psychometric analysis, mixed-effects models, and responder analyses.
Working knowledge of FDA Patient-Focused Drug Development (PFDD) guidance and relevant international regulatory frameworks.
Highly desirable:
Advanced degree (PhD, MSc, MPH or equivalent).
Experience within HIV or other infectious diseases.
Strong clinical-development and cross-functional experience.
Scientific publications, conference presentations, or participation in external working groups.
Experience translating complex measurement-science concepts for diverse scientific and operational stakeholders.
Important scheduling note:
The selected candidate will be required to take a scheduled break from work from mid-December through early January .
Employment sponsorship is not available for this position. Candidates must be authorized to work in the United States without current or future employer sponsorship.
No third-party agency or vendor submissions. We are only considering candidates applying directly for this opportunity. Please do not submit resumes on behalf of candidates.
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Worksite address
durham, NC, 27703, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.