Consultant, Clinical Outcomes Assessment
About The Position
Parexel International LLC seeks a Consultant, Clinical Outcomes Assessment reporting to headquarters in Raleigh, North Carolina to develop and lead clinical outcomes assessments (COAs) under limited supervision. This role involves acting as a project lead and technical subject matter expert (SME) for Global Clinical Outcomes Assessment studies and Real-World Evidence (RWE) studies, including instrument development and validation, and burden of condition and treatment assessment. The position requires leading the design and implementation of various patient and expert interviews and surveys, as well as ePRO implementation for Phase 2-4 trials. The Consultant will serve as an SME for the development of study materials, lead coding, analysis, and reporting for qualitative interviews, and utilize specific software for data analysis. The role also includes guiding study report development, conducting quality checking processes, supporting psychometric evaluations, adhering to regulatory guidelines, authoring publications, identifying new project opportunities, and coaching junior staff. Telecommuting is permitted from anywhere in the United States up to 5 days per week.
Requirements
- Master’s degree in Public Health, Biology, or a related field.
- At least three years of clinical outcomes assessment experience.
- At least three years of experience utilizing software including Atlas.ti and nVivo.
- At least three years of experience in delivery of qualitative clinical outcomes assessment validation projects for pharmaceutical study sponsors.
- At least three years of experience in designing and implementing cognitive debriefing and concept elicitation in-trial interviews, direct to patients and clinical experts’ surveys, and ePRO implementation for Phase 2-4 trials.
- At least three years of experience in conducting coding, analysis, and reporting for qualitative interviews, including content validation and exit interviews.
- At least three years of experience in delivery of COA strategy for Phase 2-4/RWE studies.
- At least three years of experience in ePRO implementation regulatory requirements in clinical research.
Responsibilities
- Develop and lead clinical outcomes assessments (COAs) under limited supervision.
- Act as a project lead and technical subject matter expert (SME) for Global Clinical Outcomes Assessment studies and RWE studies, including instrument development and validation, and burden of condition and treatment assessment.
- Lead the design and implementation of cognitive debriefing and concept elicitation in-trial interviews, direct to patients and clinical experts’ surveys, and ePRO implementation for Phase 2-4 trials.
- Serve as SME for the development of study materials, including study protocols, informed consent forms, recruitment materials, interview guides, qualitative analysis plans, and codebooks for ethic submissions.
- Lead coding, analysis, and reporting for qualitative interviews, including content validation and exit interviews.
- Utilize software for data analysis and interpretation, including Atlas.ti, nVivo, and MAXQDA.
- Guide study report development to summarize study overviews and convey and interpret study findings and conclusions.
- Conduct quality checking processes of study materials, reports, and presentations.
- Support psychometric evaluations of COA instruments to assess validity, reliability, and responsiveness.
- Adhere to FDA, EMA, and other relevant guidelines for COA implementation in clinical research.
- Author publications for conferences and in peer-review journals.
- Identify new project opportunities for business development and develop proposals.
- Act in a client facing role and in bid defense meetings to win new business.
- Coach and mentor junior staff and administer subject matter training.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
