Job Description

Job Title: Patient-Reported Outcomes (PRO) / Questionnaire Consultant

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.

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