ELLIE MASSERRAT
San Jose
Summary
Clinical study program leader with 17+ years directing end-to-end study execution across device and digital health programs. Experienced translating study objectives, protocols, and endpoints into structured operational plans supporting site activation, enrollment, monitoring, and data integrity in accordance with regulatory and GCP expectations. Regularly partners with investigators, clinical operations, data management, biostatistics, quality, and engineering teams to coordinate study activities, manage dependencies, and deliver reliable clinical evidence at scale. Designs study operating models, dashboards, and governance processes that provide leadership visibility into enrollment, compliance, and data quality while reducing execution risk in regulated environments. Proven record supporting high-impact studies requiring participant safety, privacy protections, audit readiness, and global cross-functional coordination. Professional Recognition: Selected for inclusion in a forthcoming Who’s Who professional publication recognizing leadership and industry impact.
Overview
8
8
years of professional experience
Work History
Technical Program & Operations Consultant
WINWIRE TECHNOLOGIES
10.2024 - Current
- Translate strategic initiatives into structured execution plans, milestones, and ownership models across engineering, research, operations, and compliance teams
- Design executive dashboards tracking progress, blockers, productivity, and program health across concurrent initiatives
- Coordinate planning sessions and leadership reviews ensuring prioritization and clear decision accountability
- Implement scalable workflows and playbooks improving execution consistency across distributed teams
- Identify performance gaps through analytics and drive process improvements reducing cycle time
- Manage vendor collaboration processes including deliverables tracking and escalation management
- Lead adoption of new systems, tools, and operational practices across stakeholders
- Prepare decision memos and document tradeoffs for leadership alignment
- Coordinate documentation readiness and compliance alignment for regulated initiatives
- Support planning, resourcing, and prioritization across competing organizational programs
Clinical Manager
G VASCULAR / TRIREME MEDICAL
10.2021 - 11.2024
- Managed global programs aligning deliverables, timelines, and resources
- Established governance cadences supporting executive oversight
- Built standardized reporting improving predictability and transparency
- Identified cross-functional risks and implemented mitigation strategies
- Coordinated clinical study operations and readiness activities
- Partnered with regulatory and quality teams ensuring audit readiness
- Prepared executive program updates with key decisions and risks
Clinical Operations Lead (Contract)
DEXCOM
01.2024 - 07.2024
- Coordinated timelines, dependencies, and deliverables across engineering, product, and clinical stakeholders
- Built tracking systems providing leadership visibility into execution readiness
- Facilitated planning meetings and ensured follow-through on action items
- Conducted workflow analysis removing operational bottlenecks
- Supported launch readiness and risk mitigation planning
- Escalated risks before milestone impact and aligned mitigation plans
- Organized cross-functional readiness reviews
- Aligned compliance and operational expectations across teams
Consultant, Clinical Trial Operations Manager / Study Manager
CVS HEALTH
12.2020 - 10.2021
- Coordinated distributed teams across multiple locations and functions
- Built centralized tracking systems ensuring accountability
- Performed gap analyses and corrective action planning
- Managed timelines across high-volume workflows
- Supported regulated study execution processes
- Communicated progress and risks to leadership
Clinical Trial Manager
HEARTFLOW, INC.
09.2017 - 12.2020
- Converted program objectives into execution milestones
- Led training improving process adoption and consistency
- Delivered executive status reporting on progress and risk
- Coordinated clinical and technical stakeholders for readiness
- Maintained documentation supporting compliance and traceability
Education
MBA - Healthcare Management
George Washington University
Graduate Certificate - Regulatory Affairs
George Washington University
BS - Biology & Biochemistry
Pennsylvania State University
Skills
- Study Planning & Protocol Execution
- Cross-Functional Study Leadership
- Site Activation & Enrollment Oversight
- Metrics & Study KPIs
- Monitoring & Data Quality Oversight
- Risk & Issue Management
- Investigator & Stakeholder Communication
- CRO & Vendor Management
- Data-Driven Study Decisions
- Study Readiness & Closeout
- TMF & Documentation Governance
- Change Control
- Clinical Operations
- Regulatory & GCP Compliance
- Operations management
- Workflow design
- Project management
- Logistics management
- Regulations
- Cross-functional team leadership
- Problem-solving
- Teamwork and collaboration
- Attention to detail
- Problem-solving abilities
- Team leadership
- Continuous improvement
- Contract negotiation
- Change management
- Regulatory compliance
- Vendor management
- Resource allocation
Timeline
Technical Program & Operations Consultant
WINWIRE TECHNOLOGIES
10.2024 - Current
Clinical Operations Lead (Contract)
DEXCOM
01.2024 - 07.2024
Clinical Manager
G VASCULAR / TRIREME MEDICAL
10.2021 - 11.2024
Consultant, Clinical Trial Operations Manager / Study Manager
CVS HEALTH
12.2020 - 10.2021
Clinical Trial Manager
HEARTFLOW, INC.
09.2017 - 12.2020
Graduate Certificate - Regulatory Affairs
George Washington University
BS - Biology & Biochemistry
Pennsylvania State University
MBA - Healthcare Management
George Washington University
LEADERSHIP & ADVISORY EXPERIENCE
Project Advisor — Digital Solutions for Veterans
2022 – Present
Advise on operational strategy, reporting frameworks, and scalable execution models
Awards
Professional Recognition: Selected for inclusion in a forthcoming Who’s Who professional publication recognizing leadership and industry impact.
Awards: Recipient of WinWire Technologies “Going the Extra Mile” Award for operational excellence, stakeholder impact, and program execution leadership.