Clinical Operations Leadership When Execution Matters Most

Programs rarely fail because of strategy alone. They stall when execution breaks down. I partner with teams to provide experienced clinical operations leadership across critical stages, from early planning and global study start-up to enrollment acceleration, vendor governance, and inspection readiness. Engagements are tailored to organizational needs, whether short- or long-term, fractional or full-time, with a consistent focus on accountability, and high-quality delivery.

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Interim & Fractional Leadership
  • Leadership for early- through global late-stage programs
  • Team structure, mentoring, and operational alignment
  • Cross-functional alignment and change management
Clinical Finance & Program Oversight
  • Budget development & forecasting
  • Vendor financial governance and change order management
Vendor Oversight & Governance
  • CRO and vendor oversight frameworks and governance models
  • eCOA/ePRO implementation
  • Rater training oversight
Study Acceleration & Rescue
  • Enrollment curve analysis
  • Enrollment rescue strategy and execution
  • Risk identification, assessment, and mitigation planning
Study Start Up & Feasibility
  • Protocol & ICF development & operational feasibility
  • IND/CTA readiness support
  • Country selection & strategy
  • Site identification and qualification
Site Management & Engagement
  • Site training & management
  • CRA visit preparedness and support
  • Site performance review
  • Site visit strategy
Inspection Readiness
  • Audit preparation, TMF quality
  • Database lock planning and execution oversight
  • Data quality and cleaning strategy
  • SOP and operational process development
Dashboard design & Analytics
  • Dashboard design and visualization
  • KPI development
  • Milestone tracking

How I Partner

Embedded or Interim Leadership

Short- or long-term | Full-time or fractional

Hands-on clinical operations leadership during periods of transition, growth, or increased complexity. Engagements may be full-time, interim, or embedded within existing teams to provide continuity and executional rigor.

Fractional Leadership

Typically 10–30 hours per week

Strategic and operational support for organizations that need experienced leadership without a full-time hire. Ideal for early-stage programs, portfolio expansion, or targeted operational build-out.

Project-Based or Study-Specific Support

Fixed-scope or milestone-based

Focused support for defined deliverables such as study start-up, vendor selection, study rescue, or inspection readiness, with clear scope, timelines, and accountability.

Long-Term Consulting or Full-Time (FTE) Roles

Flexible engagement structure

Available for longer-term consulting, employer-of-record (W-2) arrangements, or permanent leadership roles when alignment and organizational needs warrant.

Testimonials

“I’ve had the privilege of working alongside Holly for almost three years at Sage Therapeutics. Holly consistently demonstrated herself to be an exceptionally talented clinical development leader. She brings a rare combination of scientific rigor, strategic thinking, and a genuine collaboration to every project she touches. Holly has a deep understanding of clinical development processes and an ability to translate complex concepts into clear, actionable plans that drive results.”

Kathryn Lunga, Director of Clinical Operations & Development, formerly at Sage Therapeutics

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