Clinical Outcome Assessments Manager

Voluntary Protection Programs Participants' Association, Inc.; Durham, Northern (NC, KY); Hybrid; USD 90,000 - 110,000; Full time

Benefits offered by this job

Flexible work options

Onsite/Remote options

Job summary

Voluntary Protection Programs Participants' Association, Inc. is seeking a Clinical Outcome Assessments Manager to advance patient-centered measurement across clinical development programs, shaping COA strategies and supporting regulatory interactions.

The role focuses on COA development, validation, instrument adaptation, data analysis, and cross‑functional collaboration with Clinical Development, Regulatory, Biostatistics, Medical Affairs, and Clinical Operations.

Qualifications

• Experience with COAs, patient-centered outcomes, or measurement science disciplines.
• Knowledge of qualitative methods, psychometrics, and statistics in clinical development.
• Familiarity with regulatory standards for patient-focused evidence and COA strategies.
• Strong communication and cross-functional collaboration skills.
• Eligible to work in the US and willing to take a mid‑December to early January break.

Responsibilities

• Contribute to design and execution of COA development and validation studies.
• Support selection, adaptation, development, validation, and implementation of COA instruments.
• Apply qualitative and psychometric methods to evaluate COA properties.
• Deliver COA strategy outputs within established timelines.
• Support regulatory engagements related to patient-focused evidence and COA plans.
• Prepare materials for interactions with regulatory agencies and stakeholders.
• Incorporate regulatory feedback into COA development plans.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and Clinical Operations.

Skills

COA measurement science

Qualitative research

Statistical analysis

Regulatory standards knowledge

Cross-functional collaboration

Regulatory engagement

Communication skills

Eligibility to work in US

Education

Bachelor's degree in relevant field

Job description

Are you passionate about ensuring the patient voice is reflected throughout the drug development process? Join a global healthcare organization where you'll help shape patient-centered outcomes strategies, influence clinical development programs, and support innovative HIV treatment and prevention research.

Location: Durham, NC (Onsite or Remote)
Pay Rate: $65-$80/hour
Employment Type: Contingent
Schedule: Normal Business Hours / Core Hours

Why This Role Matters

As a Clinical Outcome Assessments Manager, you will play a critical role in advancing patient-focused evidence generation across clinical development programs. Your expertise in measurement science, clinical outcome assessments (COAs), and patient-centered outcomes will help ensure meaningful patient experiences are incorporated into research, regulatory strategies, and healthcare decision‑making.

What You'll Do

• Contribute to the design and execution of COA development and validation studies, including collection and analysis of patient experience data
• Support the selection, adaptation, development, validation, and implementation of COA instruments for clinical trials and observational studies
• Apply qualitative research methods, psychometric principles, and statistical techniques to evaluate measurement properties of COAs
• Deliver high‑quality measurement science outputs and COA strategy deliverables within established timelines
• Support regulatory engagement activities related to patient‑focused evidence generation and COA strategies
• Prepare materials for interactions with regulatory agencies and external stakeholders
• Incorporate regulatory feedback into COA development and implementation plans
• Collaborate with cross‑functional teams including Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and Clinical Operations

What We're Looking For

• A current, up‑to‑date resume
• Bachelor's degree in Psychometrics, Health Outcomes Research, Epidemiology, Biostatistics, Public Health, Behavioral Science, Biomedical Engineering, Data Science, or a related field
• 3+ years of relevant experience in pharmaceutical, biotechnology, digital health, CRO, or academic environments
• Demonstrated expertise in Clinical Outcome Assessments (COAs), patient‑centered outcomes, or measurement science disciplines
• Experience with qualitative research methodologies, psychometrics, and statistical analysis techniques
• Strong understanding of regulatory standards related to patient‑focused evidence and outcome assessments
• Excellent communication and cross‑functional collaboration skills
• Ability to take an extended work break from mid‑December through early January, as required for the assignment
• Ability to meet compliance requirements
• Must be eligible and provide proof of eligibility to work in the US

What's In It For You

• Opportunity to support innovative HIV treatment and prevention programs
• Flexible work arrangement with onsite or remote options
• Exposure to global clinical development and regulatory initiatives
• Collaborative environment with cross‑functional healthcare and research professionals
• Competitive hourly pay rate
• Opportunity to make a meaningful impact on patient‑centered healthcare research

Benefits for Manpower Associates (Upon Eligibility)

Upon completion of waiting period associates are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Supplemental Life Insurance
• Short Term Disability Insurance
• 401(k)