Vitalief Inc.

Clinical Research

• Serve as the lead Clinical Research SME for the engagement, guiding all aspects of the operational assessment and change management strategy.
• Conduct in-depth interviews with clinical research staff and stakeholders across the clinical trial lifecycle to identify operational gaps, bottlenecks, communication challenges, and improvement opportunities across Oncology and Non-Oncology programs.
• Partner with executive and operational stakeholders to assess organizational readiness for change and recommend sustainable transformation strategies.
• Collaborate with the Vitalief team to design effective interview templates, assessment methodologies, and change management frameworks.
• Evaluate current-state workflows, governance structures, staffing models, and technology utilization to identify opportunities for operational alignment and standardization.
• Compare Oncology and Non-Oncology operations to identify transferable best practices and opportunities for cross-functional integration.
• Develop prioritized, actionable recommendations that address immediate operational challenges while supporting long-term scalability and organizational adoption.
• Create and present a clear transformation roadmap focused on operational excellence, stakeholder engagement, process optimization, and effective cross-system coordination.
• Provide regular project status updates to executive stakeholders, ensuring alignment, transparency, and on-time delivery of engagement milestones.
• Deliver executive-level presentations summarizing findings, recommendations, change impacts, and measurable next steps.

Clinical Research Change Management Consultant

Financial Planning and Analysis

• Develop, build, and finalize clinical trial budgets for industry-sponsored studies (oncology and non-oncology)
• Perform detailed Medicare Coverage Analyses (MCA) to accurately distinguish routine care vs. research-related costs
• Configure and maintain study calendars, budgets, and billing grids within OnCore
• Support clinical trial start-up by ensuring accurate budget setup, billing designation, and downstream readiness
• Lead or support budget negotiations with sponsors and CROs
• Partner closely with investigators, study coordinators, finance, and revenue cycle teams to validate assumptions
• Conduct ongoing budget tracking, reconciliation, and variance analysis
• Identify and address billing compliance risks
• Assist in audit readiness activities
• Standardize and improve budgeting and coverage analysis workflows
• Serve as a subject matter expert for clinical trial budgeting, billing compliance, and OnCore functionality
• Provide hands-on support across multiple client engagements

Clinical Research Change Management Consultant

Senior Clinical Trials Budget Analyst