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)

Manpower

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Clinical Outcome Assessments Manager