Clinical Outcome Assessments Manager

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

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.

• 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

• 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

• 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

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)