Consultant, Clinical Outcomes Assessment

Consultant, Clinical Outcomes Assessment

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Job location:

541 Church at North Hills St., Suite 1000, Raleigh, NC 27609. Position may telecommute from anywhere in the US up to 5 days per week.

Duties:

• Develop and lead clinical outcomes assessments (COAs) under limited supervision.
• Act as a project lead and technical subject matter expert for global clinical outcomes assessment studies and real-world evidence studies.
• 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 ethics 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.

Requirements:

• Master's degree in Public Health, Biology, or a related field plus at least three years of clinical outcomes assessment experience.
• At least three years of experience in each of the following: utilizing software including Atlas.ti and nVivo; delivery of qualitative clinical outcomes assessment validation projects for pharmaceutical study sponsors; 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; conducting coding, analysis, and reporting for qualitative interviews, including content validation and exit interviews;
  
  delivery of COA strategy for Phase 2-4/RWE studies; and ePRO implementation regulatory requirements in clinical research.

EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.