Remote COA Manager: HIV Clinical Outcomes

alphanumeric; Durham, Northern (NC, KY); Hybrid; USD 69,000 - 74,000; Full time

Job summary

Alphanumeric in Durham, NC is seeking a Clinical Outcome Assessments Manager to support ViiV Healthcare's Global Health Outcomes team. This role offers remote or onsite work with core business hours and an hourly pay range of $50.00–$54.00.

The candidate will help develop, validate, and implement COA instruments for trials and observational studies, collaborating across Biostatistics, Regulatory Affairs, Medical Affairs, and Clinical Operations.

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 settings with demonstrated expertise in COAs, patient-centered outcomes, or related measurement science.
• Experience contributing to COA development, validation, or implementation 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 PFDD guidance and relevant international regulatory frameworks.

Responsibilities

• 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.

Skills

COA development

Patient-centered outcomes

Psychometrics

Health outcomes

Measurement science

Biostatistics

Regulatory knowledge

Education

Bachelor's degree in relevant field

Tools

SAS

R

Job description

Alphanumeric in Durham, NC is seeking a Clinical Outcome Assessments Manager to support ViiV Healthcare's Global Health Outcomes team. This role offers remote or onsite work with core business hours and an hourly pay range of $50.00–$54.00.

The candidate will help develop, validate, and implement COA instruments for trials and observational studies, collaborating across Biostatistics, Regulatory Affairs, Medical Affairs, and Clinical Operations.