Consultant, Clinical Outcomes Assessment

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.

About the role

Parexel International LLC seeks a Consultant, Clinical Outcomes Assessment to develop and lead clinical outcomes assessments (COAs) under limited supervision. This role acts as a project lead and technical subject matter expert (SME) for Global Clinical Outcomes Assessment studies and RWE studies.

Responsibilities

• Develop and lead clinical outcomes assessments (COAs) under limited supervision (10%)
• Act as project lead and technical SME for Global Clinical Outcomes Assessment studies and RWE studies, including instrument development and validation, and burden of condition and treatment assessment (10%)
• 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 (15%)
• 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 (20%)
• Lead coding, analysis, and reporting for qualitative interviews, including content validation and exit interviews (5%)
• Utilize software for data analysis and interpretation, including Atlas.ti, nVivo, and MAXQDA (5%)
• Guide study report development to summarize study overviews and convey and interpret study findings and conclusions (10%)
• Conduct quality checking processes of study materials, reports, and presentations (3%)
• Support psychometric evaluations of COA instruments to assess validity, reliability, and responsiveness (2%)
• Adhere to FDA, EMA, and other relevant guidelines for COA implementation in clinical research (3%)
• Author publications for conferences and in peer-review journals (2%)
• Identify new project opportunities for business development and develop proposals (8%)
• Act in a client-facing role and in bid defense meetings to win new business (5%)
• Coach and mentor junior staff and administer subject matter training (2%)

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
  • ePRO implementation regulatory requirements in clinical research

Pay

Annual salary: $119,440 to $179,160

Schedule

Telecommuting permitted from anywhere in the United States 5 days per week.