Remote COA Strategy Lead – Patient-Centered Outcomes

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

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.