Summary
Work History
Education
Skills
Timeline
LEADERSHIP & VOLUNTEERING
Generic
ELLIE MASSERRAT

ELLIE MASSERRAT

Summary

Accomplished Clinical Operations and Systems Leader with 17+ years of experience in clinical documentation management, regulatory compliance, and inspection readiness across global life sciences organizations. Proven expertise in ensuring TMF quality, process harmonization, and data integrity in alignment with ICH-GCP, ALCOA+, and TMF Reference Model standards. Adept at leading cross-functional teams and external vendors to drive operational excellence, audit preparedness, and system integrations. Recognized for strategic leadership in clinical systems transformation, quality oversight, and end-to-end documentation lifecycle management.

Experienced with analyzing and optimizing IT systems to support business objectives. Utilizes technical expertise and strategic planning to implement effective solutions and enhance system performance. Track record of strong communication and project management skills, ensuring successful collaboration and timely project completion.

Work History

Clinical Systems Consultant

WinWire Technologies
10.2024 - Current
  • Lead documentation governance and TMF-related system enhancement projects to align digital health and regulatory systems with compliance standards.
  • Collaborate with QA, Regulatory, Clinical, and IT partners to standardize document workflows and strengthen inspection readiness controls.
  • Design KPI dashboards and audit trackers for document quality, completeness, and compliance performance.
  • Partner with cross-functional leaders to prioritize TMF-related process improvements and change initiatives.
  • Recognized with WinWire’s “Going the Extra Mile” Award (2025) for advancing inspection readiness and training initiatives.

Clinical Operations Lead Manager (Contract)

Dexcom
01.2024 - 07.2024
  • Oversaw documentation compliance and audit preparedness across multiple clinical studies.
  • Partnered with Clinical Affairs, Data Management, and Quality teams to streamline TMF workflows and ensure adherence to SOPs.
  • Led document QC activities, issue resolution, and risk mitigation plans aligned with inspection readiness goals.
  • Improved documentation turnaround and cross-functional visibility through enhanced reporting and dashboard tracking.

Clinical Manager

G Vascular / TriReme Medical
10.2021 - 11.2023
  • Directed global documentation activities supporting CE Mark and 510(k) submissions, ensuring audit-ready TMFs.
  • Managed vendor oversight, document QC, and compliance with ICH-GCP and internal SOPs.
  • Coordinated integration of clinical and regulatory records during partnership transitions.
  • Enhanced data accuracy and submission readiness via standardized audit checklists and document lifecycle tracking.

Clinical Trial Services Consultant

CVS Health
12.2020 - 10.2021
  • Supported document management and quality tracking for large-scale COVID-19 Phase 3 trials.
  • Collaborated with compliance teams to ensure GCP alignment and audit readiness.
  • Developed central dashboards monitoring TMF metrics and regulatory submission timelines.

Clinical Trial Manager

HeartFlow, Inc.
09.2017 - 12.2020
  • Managed TMF documentation, training, and CAPA activities to strengthen inspection readiness across multiple global trials.
  • Partnered with Quality and Regulatory teams on audit preparation and documentation improvement initiatives.
  • Led cross-functional meetings to ensure timely document submission, QC closure, and alignment with TMF Reference Model.

Education

MBA - Healthcare Management

The George Washington University

Graduate Certificate - Regulatory Affairs

The George Washington University

B.S. - Biology & Biochemistry

The Pennsylvania State University

ICSB Certificate - Creativity & Innovation

01.2020

Skills

  • TMF Oversight & Compliance (ICH-GCP, ALCOA, EDLs)
  • Veeva Vault (eTMF/CTMS) Management & Migration
  • Inspection Readiness & CAPA Management
  • Quality Risk Mitigation & Documentation Governance
  • Clinical Operations & Regulatory Systems Alignment
  • Process Improvement & Change Management
  • Cross-Functional & Vendor Leadership
  • Project Planning, Metrics, & Resource Optimization
  • Communication, Presentation, & Stakeholder Engagement

Timeline

Clinical Systems Consultant

WinWire Technologies
10.2024 - Current

Clinical Operations Lead Manager (Contract)

Dexcom
01.2024 - 07.2024

Clinical Manager

G Vascular / TriReme Medical
10.2021 - 11.2023

Clinical Trial Services Consultant

CVS Health
12.2020 - 10.2021

Clinical Trial Manager

HeartFlow, Inc.
09.2017 - 12.2020

Graduate Certificate - Regulatory Affairs

The George Washington University

B.S. - Biology & Biochemistry

The Pennsylvania State University

ICSB Certificate - Creativity & Innovation

MBA - Healthcare Management

The George Washington University

LEADERSHIP & VOLUNTEERING

Prize LLC, Project Advisor, Digital Solutions for Veterans, 2022-08, Present, Guide the design and documentation strategy for digital health systems improving patient engagement and compliance., Oversee planning, reporting, and data governance initiatives across cross-functional teams.

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