Open to opportunities

Carmela Graci Pipitone

@carmelagracipipitone

Message

Clinical operations leader driving global oncology programs from FIH to late-stage.

United States

Message

What I'm looking for

I seek a senior clinical operations role in biotech where I can lead global oncology programs, improve vendor governance, ensure inspection readiness, mentor teams, and drive on-time, compliant study delivery.

I am a strategic, execution-focused clinical operations leader with over 20 years of experience running global Phase I–III programs across oncology and multiple therapeutic areas. I translate development plans into executable timelines, budgets, and cross-functional deliverables to drive on-time, high-quality program milestones.

I have deep expertise in CRO/vendor governance, clinical risk management, regulatory readiness, and inspection-ready quality frameworks, and I have led CRO selection, SOW review, and KPI-driven governance to improve protocol compliance and study performance.

My hands-on approach includes directing TMF quality oversight, implementing risk mitigation strategies, and owning study-level financial forecasting and variance management. I have supervised and mentored CRAs and site teams, supported audits/inspections, and led UAT for EDC/IRT tools to ensure fit-for-purpose systems.

I thrive in dynamic biotech environments where I can build trust, drive accountability, and scale processes for growth while ensuring operational continuity across Clinical Development, Biometrics, Regulatory, Safety, and Quality.

Experience

Work history, roles, and key accomplishments

Senior Clinical Study Manager

Zentalis Pharmaceuticals

Jul 2024 - Jan 2026 (1 year 6 months)

Provided end-to-end oversight of global oncology studies (including first-in-human), delivering milestones within forecasted budgets and ensuring inspection-ready documentation and ICH/GCP compliance.

Clinical Operations CRO Management Risk Management Protocol ICF Development

Clinical Study Manager

Zentalis Pharmaceuticals

Aug 2021 - Jul 2024 (2 years 11 months)

Managed study-level activities including ClinicalTrials.gov submissions, biosample operations, vendor selection, and training to support compliant execution and data integrity.

Vendor Selection CRF Protocol Support Sample Tracking RFP Management Training

Clinical Team Lead

Manhattan Medical Research

May 2012 - Aug 2021 (9 years 3 months)

Directed day-to-day site operations for Phase II–IV trials across oncology and other therapeutic areas, improving recruitment/retention and ensuring audit-ready documentation.

Site management GCP Compliance Staff Supervision Budget Management

Senior Clinical Research Coordinator

University Urology Associates

Feb 2007 - Aug 2021 (14 years 6 months)

Coordinated multiple Phase II–IV trials, managing informed consent, safety monitoring, CRFs, and query resolution to support timely database lock and inspection readiness.

Patient Coordination Monitoring CRF Query Resolution

Clinical Research Coordinator

Eastside Comprehensive Medical Center

Supported clinical research activities including participant screening, visit coordination, and data capture to maintain protocol adherence and quality source documentation.

Participant Screening GCP Site Support

Medical Assistant

University Urology Associates

Provided clinical support for research and patient care activities, assisting with procedures, documentation, and coordination to facilitate trial conduct.

Clinical Support Patient Care Documentation Scheduling