[Remote] Clinical Project Manager II (PHD Epidemiology, HEOR)

Note: The job is a remote job and is open to candidates in USA. The Fountain Groups is a company focused on patient-centered outcomes research, and they are seeking a Clinical Project Manager II to optimize product registration and access through the generation of patient experience data in oncology studies. This role involves designing and executing patient experience data strategies, collaborating with various teams, and conducting rigorous analyses of clinical outcomes.

Responsibilities
• Conducts literature & landscape reviews to develop disease conceptual models focused on patient-centered outcomes in oncology
• Identifies & statistically evaluates existing COA tools, determining fit-for-purpose through rigorous quantitative analysis (with an emphasis on oncology when possible)
• Leads development, validation, and integration of COA measurement strategy into clinical development, including protocol/SAP content development, advanced results interpretation, and reporting
• Designs and executes PED research using a variety of quantitative methods, including psychometric analyses (e.g., factor analysis, reliability/validity testing) and statistical programming for COA endpoint analysis in clinical trials (oncology)
• Develops high-level technical content for regulatory and reimbursement submissions, translating complex quantitative findings into reporting documents
• Drives strategic scientific communication, including data-rich publications and presentations at peer-reviewed journals and medical congresses (with focus on oncology when feasible)
• Contributes to best practices for quantitative PED/COA analysis and provides education to internal stakeholders to advance the integration of the patient voice
• Manages high-quality publication processes, ensuring statistical rigor and scientific integrity in all communications

Skills
• PHD in Epidemiology, HEOR
• At least 3 years direct research experience with strong hands-on quantitative and statistical analysis in clinical trials and Patient Reported Outcomes/Clinical Outcome Assessment (PRO/COA) data in oncology
• Deep understanding of measurement science principles, advanced psychometric/statistical methods, and their application in clinical research
• Proven experience developing and implementing statistical analysis plans (SAPs) for clinical outcomes (oncology)
• Ability to synthesize complex quantitative healthcare data into actionable insights for various stakeholders, including regulatory audiences
• Strong project management and communication skills, with a track record of collaboration across multifunctional teams in a clinical or healthcare environment
• Familiarity with clinical trial design, industry compliance standards, and requirements for regulatory documentation regarding COA endpoints
• Demonstrated initiative, strong work ethic, and the ability to manage multiple projects with competing priorities in a fast-paced environment
• Strong quantitative and statistical abilities for developing robust research plans, advanced statistical analysis plans, and conducting rigorous analyses of PRO and COA endpoints across oncology portfolios
• Deep familiarity with psychometric and statistical methods for validating and analyzing COAs in clinical trials (oncology experience preferred but not required)

Company Overview
• The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. It was founded in 2001, and is headquartered in Tampa, Florida, US, with a workforce of 501-1000 employees. Its website is http://www.TheFountainGroup.org.

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