Clinical Outcome Assessments Manager

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

Job summary

ViiV Healthcare in Durham, NC is seeking a Clinical Outcome Assessments (COA) Manager to support the Global Health Outcomes team. This role focuses on HIV treatment and prevention, developing and validating COA instruments, patient-centered endpoints, and regulatory strategy.

The position allows remote or onsite work with core business hours and offers hourly pay of $50.00 - $54.00. The candidate will collaborate across functions to design COA studies, support FDA interactions, and contribute to

Qualifications

• Experience with Clinical Outcome Assessments and patient-centered outcomes.
• Experience developing, validating, or implementing COA instruments.
• Familiarity with statistical approaches for COA and digital endpoints.

Responsibilities

• Support design and execution of COA development and validation studies.
• Select and implement COA instruments for trials and observational research.
• Apply qualitative methods and psychometrics to evaluate measurement properties.
• Support FDA and health authority interactions related to COA strategies.
• Contribute to regulatory submissions, endpoint rationale, and SAP language.
• Collaborate with Biostatistics, Regulatory Affairs, Medical Affairs, and Clinical Operations.
• Support publications and conference presentations.
• Promote measurement-science standards and COA best practices.

Skills

COA expertise

PRO measures

Psychometrics

Health outcomes research

Measurement science

Regulatory strategy collaboration

Education

Bachelor's degree in health outcomes or related field

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 a Clinical Outcome Assessments (COA) Manager to support the ViiV Healthcare Global Health Outcomes team.

This is a scientific, measurement-focused role supporting ViiV's drug development portfolio across HIV treatment and prevention. The successful candidate will contribute to the development, validation, and implementation of Clinical Outcome Assessment instruments and patient-centered endpoints used in clinical trials and observational studies.

This is an excellent opportunity for someone with a background in COA, 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.