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)
