Job Description
job summary:
The Patient-Centered Outcomes Manager is a scientific role within the
ViiV Healthcare Global Health Outcomes Team , responsible for delivering high-quality clinical outcome assessment (COA) strategies and measurement science support across ViiV's drug development portfolio. This role supports the needs of multiple stakeholders by ensuring patient-centered outcomes are effectively incorporated into clinical development programs.
Working under the direction of the Pipeline Lead, the Manager applies measurement science expertise to support the development, validation, and implementation of COA instruments. The role also contributes to the planning and execution of regulatory engagement strategies related to COAs.
The Manager plays a key role in developing integrated evidence plans across HIV treatment and prevention programs. They collaborate cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and Clinical Operations teams to ensure patient-centered endpoints are appropriately defined, validated, and implemented in clinical trials and observational studies.
This position requires strong scientific expertise, knowledge of regulatory standards, and a commitment to advancing measurement science to ensure the patient voice is reflected in demonstrating the value of ViiV's products.
location: Durham, North Carolina
job type: Contract
salary: $52.00 - 54.81 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
COA Strategy and Scientific Delivery - Contribute to the design and execution of COA development and validation studies, including the collection and analysis of patient experience data.
- Support the selection, adaptation, development, validation, and implementation of COA instruments for use in clinical trials and observational studies.
- Apply qualitative research methodologies, psychometric principles, and statistical techniques to evaluate COA measurement properties.
- Maintain accountability for the quality and timely delivery of measurement science outputs, including COA strategy deliverables.
Regulatory and External Engagement - Contribute to regulatory engagement activities and support the development of documentation related to COA strategies and patient-focused evidence generation.
- Assist in preparing materials for interactions with regulatory agencies and external stakeholders regarding COA-related initiatives.
- Support the incorporation of regulatory feedback into COA development and implementation plans.
qualifications:
- Education: 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 in pharmaceutical, biotechnology, digital health, CRO, or academic settings, with demonstrated expertise in COAs, patient-centered outcomes, or related measurement science disciplines.
skills: Epidemiology, CRO Oversight
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Job Tags
Hourly pay, Contract work, Temporary work, Work experience placement