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.