Remote COA Manager: PRO & Measurement Science

Alphanumeric Systems; Durham (NC); Hybrid; USD 69,000 - 74,000; Full time

Job summary

ViiV Healthcare is seeking a Clinical Outcome Assessments Manager in Durham, NC, with remote or onsite options. The role focuses on COA instrument development, validation, and implementation across HIV treatment and prevention programs.

The position requires a strong background in COA, PRO, psychometrics, and health outcomes research, plus collaboration with regulatory teams to support submissions and strategy.

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 disciplines.
• 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.

Responsibilities

• Design and execution of COA development and validation studies, including patient-experience data collection and analysis.
• Select, adapt, develop, validate, and implement COA instruments for clinical trials and observational research.
• Apply qualitative research methods, psychometric principles, and statistical approaches to evaluate measurement properties.
• Support FDA and other health authority interactions related to COA and patient-centered endpoint strategies.
• Contribute to briefing documents, regulatory submissions, endpoint rationale, protocols, SAP language, and responses to health authority questions.
• Partner cross-functionally with Biostatistics, Regulatory Affairs, Medical Affairs, Clinical Development, R&D, and Clinical Operations.
• Support publications, conference presentations, and other external scientific activities.
• Help advance measurement-science standards and COA best practices across the portfolio.

Skills

COA expertise

Patient-centered outcomes

Psychometrics

Statistical analysis

Regulatory knowledge

Education

Bachelor's degree in psychometrics/health outcomes/epidemiology/biostatistics/public health/behavioral science

Job description

ViiV Healthcare is seeking a Clinical Outcome Assessments Manager in Durham, NC, with remote or onsite options. The role focuses on COA instrument development, validation, and implementation across HIV treatment and prevention programs.

The position requires a strong background in COA, PRO, psychometrics, and health outcomes research, plus collaboration with regulatory teams to support submissions and strategy.