PRO / Questionnaire Consultant

Medasource; Chicago (IL); Remote; USD 150,000 - 220,000; Part time

Job summary

An established industry player is looking for a detail-oriented PRO/Questionnaire Consultant to enhance patient-reported outcomes and survey instruments. This role involves collaborating with cross-functional teams to ensure that surveys are scientifically robust and user-friendly. You will design and validate questionnaires, ensuring compliance with regulatory standards while conducting psychometric analyses. If you are passionate about improving health outcomes through innovative research and have a strong background in questionnaire design, this is an exciting opportunity to make a significant impact in the healthcare sector.

Qualifications

• Experience with PRO development and psychometrics in research or clinical settings.
• Familiarity with regulatory guidelines like FDA PRO guidance.

Responsibilities

• Design and refine PRO instruments for clinical trials and research studies.
• Conduct literature reviews to support instrument development.

Skills

Questionnaire Design

Psychometrics

Regulatory Standards

Analytical Skills

Project Management

Communication Skills

Education

Bachelor's Degree in Public Health

Master's Degree in Psychology

PhD in a related field

Tools

SPSS

R

SAS

Job description

Direct message the job poster from Medasource

Remote

Job Overview:

We are seeking a detail-oriented and experienced PRO/Questionnaire Consultant to support the development, evaluation, and implementation of Patient-Reported Outcomes (PROs) and other survey-based instruments. The ideal candidate will bring strong expertise in questionnaire design, validation methodologies, and regulatory standards. You will collaborate with cross-functional teams to ensure that survey instruments are scientifically robust, user-friendly, and aligned with research or regulatory requirements.

Key Responsibilities:

• Design, review, and refine PRO instruments and other questionnaires for clinical trials, research studies, or customer feedback projects.
• Conduct literature reviews and gap analyses to support instrument development and adaptation.
• Ensure instruments meet regulatory guidelines (e.g., FDA, EMA, ISOQOL) and are culturally and linguistically appropriate.
• Develop documentation for instrument validation, including conceptual frameworks and cognitive interview guides.
• Support psychometric analyses (e.g., reliability, validity, responsiveness).
• Liaise with translation vendors and linguistic validation partners when required.
• Collaborate with internal teams (e.g., clinical, biostatistics, regulatory, UX research) and external stakeholders.
• Provide training or guidance to team members and clients on best practices in PRO and questionnaire development.
• Prepare and contribute to reports, presentations, and publications related to survey instrument development and outcomes.

Requirements:

• Bachelor's or Master's degree in Public Health, Psychology, Sociology, Epidemiology, or related field. PhD preferred for senior roles.
• Proven experience with PRO development, psychometrics, and/or questionnaire design in a research, clinical, or consulting setting.
• Familiarity with regulatory requirements and industry guidelines (e.g., FDA PRO guidance, COSMIN, ISOQOL).
• Experience conducting cognitive interviews and usability testing.
• Strong analytical, documentation, and project management skills.
• Excellent written and verbal communication abilities.
• Proficiency in statistical software (e.g., SPSS, R, SAS) is a plus.

Preferred Qualifications:

• Experience with digital health technologies and ePRO systems.
• Background in health outcomes research or market research.
• Multilingual skills or experience working with multinational studies.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Part-time

Job function

• Job function

  Writing/Editing and Science

• Industries

  Hospitals and Health Care, Pharmaceutical Manufacturing, and Biotechnology Research

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