Senior Clinical Operations Consultant | CRO Oversight & Program Execution Risk
I am a senior clinical operations consultant with over 20 years of experience supporting biotech and pharma sponsors across Phase I–III development. My work focuses on clinical trial execution, CRO oversight, and early identification of operational risk that can compromise timelines, quality, or inspection readiness.
I am typically engaged on a part-time or project basis to provide independent assessment, stabilization, or interim program leadership for complex or high-consequence studies. My background includes sponsor-side leadership, CRO delivery, and investigator experience, allowing me to quickly identify structural gaps between plans, data signals, and actual execution.
Engagements are structured, time-bound, and outcome-focused. I work best with teams that value clarity, accountability, and early intervention over reactive firefighting.
Work Terms
I engage on a project-based or fractional advisory basis to support sponsors with clinical trial execution, CRO oversight, and program stabilization. Engagements are structured, time-bound, and begin with a clearly defined scope, objectives, and deliverables.
Typical work includes independent evaluation of CRO performance, execution risk reviews, study start-up or mid-study remediation, critical path realignment, and inspection-readiness support. I do not take open-ended task coordination or staff-augmentation assignments.
I work remotely with scheduled meetings as needed and collaborate closely with sponsor leadership and cross-functional teams. Successful engagements are characterized by transparency, availability of relevant information, and a shared expectation for decisive action when risks are identified.
Availability is part-time or project-based. Engagement length and cadence are determined upfront to ensure focus and measurable outcomes. My role is to provide experienced judgment, early signal detection, and actionable recommendations—not to replace internal operational staff.