Clinical Project Manager - Patient Experience Data and Strategy

Collabera is a leading company in the Pharmaceutical industry seeking a Senior Manager, Patient Experience Data and Strategy. This role is critical in designing and executing patient experience data strategies within oncology clinical development programs, focusing on optimizing product registration and access through the analysis of patient-centered outcomes data.

Responsibilities:

• Conduct literature and landscape reviews to develop disease conceptual models centered on patient focused outcomes within oncology programs
• Identify and statistically evaluate existing clinical outcome assessment tools to determine fitness for purpose using rigorous quantitative methodologies
• Lead the development, validation, and integration of clinical outcome assessment measurement strategies within clinical development programs, including protocol and statistical analysis plan content development
• Design and execute patient experience data research using advanced quantitative methods such as factor analysis, reliability and validity testing, and statistical programming for endpoint analysis in clinical trials
• Develop high level technical documentation to support regulatory and reimbursement submissions by translating complex quantitative findings into clear and actionable insights
• Drive strategic scientific communication efforts including publication development and presentations at peer reviewed journals and medical congresses
• Establish and promote best practices for quantitative patient experience data and clinical outcome assessment analysis across multifunctional teams
• Manage publication processes to ensure statistical rigor, scientific integrity, and alignment with regulatory expectations

Requirements:

• Advanced degree such as MS, MPH, PharmD, or PhD in Biostatistics, Epidemiology, Health Economics and Outcomes Research, Public Health, or a related quantitative discipline
• Minimum of 3 years of direct research experience with strong hands on quantitative and statistical analysis of clinical trial and patient reported outcome or clinical outcome assessment data
• Deep understanding of measurement science principles and advanced psychometric and statistical methodologies applied in clinical research
• Proven experience developing and implementing statistical analysis plans for clinical outcomes research
• Strong ability to synthesize complex healthcare data into insights suitable for regulatory and cross functional stakeholders
• Demonstrated experience collaborating within multifunctional teams in clinical or healthcare environments
• Experience in oncology clinical development programs
• Experience supporting regulatory submissions involving clinical outcome assessment endpoints
• Experience presenting data at scientific congresses and publishing in peer reviewed journals