Michael Addario
Pelham
Summary
Strategic Clinical Operations Leader with 20+ years of experience driving excellence in high-stakes medical, technical, and clinical research environments. Expert in the end-to-end execution of Phase I–III clinical trials, with a specialized focus on mobile delivery and decentralized trial (DCT) models. Proven Subject Matter Expert (SME) in neuro-visual diagnostics, possessing a unique blend of "boots-on-the-ground" field expertise and high-level strategic oversight of multi-million dollar P&L budgets.
Overview
31
31
years of professional experience
1
1
Certification
Work History
Clinical Operations Lead & National SME
20/20 ONSITE
02.2020 - 10.2025
- Strategic Field Leadership: Directed a portfolio of nationwide clinical trials with 100% independence, managing all logistics and mobile unit deployment across the contiguous United States.
- MostVR Subject Matter Expert (SME) & Certifier: Lead technical authority for the MostVR platform. Accountable for the architectural setup, technical calibration, and official certification of clinical training rooms to meet rigorous study-specific regulatory standards.
- Workforce Quality Oversight: Authorized to educate and certify the clinical workforce; personally trained and certified 15+ clinical technicians on MostVR administration to eliminate 'human-error' variables in diagnostic data.
- High-Stakes Protocol Execution: Led site-level operations for high-profile trials including Xenon X-TOLE (Ph 3) and X-NOVA (Ph 3), maintaining a flawless audit trail across complex CNS and neuro-visual endpoints.
- SOP Authoring: Developed and refined Standard Operating Procedures (SOPs) for decentralized mobile units, optimizing 'Site-Initiation' workflows and increasing data reliability.
- Advanced Technical Diagnostics: Performed high-complexity diagnostics (OCT, MAIA, ETDRS Refraction) while maintaining Emmes Certification (Site & Clinician), ensuring 100% GCP/HIPAA compliance.
Clinical Operations Lead & National SME
20/20 ONSITE
02.2020 - 10.2025
- Strategic Field Leadership: Directed a portfolio of nationwide clinical trials with 100% independence, managing all logistics and mobile unit deployment across the contiguous United States.
- MostVR Subject Matter Expert (SME) & Certifier: Lead technical authority for the MostVR platform. Accountable for the architectural setup, technical calibration, and official certification of clinical training rooms to meet rigorous study-specific regulatory standards.
- Workforce Quality Oversight: Authorized to educate and certify the clinical workforce; personally trained and certified 15+ clinical technicians on MostVR administration to eliminate 'human-error' variables in diagnostic data.
- High-Stakes Protocol Execution: Led site-level operations for high-profile trials including Xenon X-TOLE (Ph 3) and X-NOVA (Ph 3), maintaining a flawless audit trail across complex CNS and neuro-visual endpoints.
- SOP Authoring: Developed and refined Standard Operating Procedures (SOPs) for decentralized mobile units, optimizing 'Site-Initiation' workflows and increasing data reliability.
- Advanced Technical Diagnostics: Performed high-complexity diagnostics (OCT, MAIA, ETDRS Refraction) while maintaining Emmes Certification (Site & Clinician), ensuring 100% GCP/HIPAA compliance.
General Manager & Corporate NPS Mentor
LENSCRAFTERS
06.2012 - 08.2017
- Executive Mentorship: One of two GMs selected based on merit to work with corporate executives as an NPS Mentor, training regional managers on providing exceptional patient experiences and testing pilot-group behaviors.
- Financial Stewardship: Full P&L ownership of high-volume medical/retail operations, managing multi-million dollar annual budgets and driving regional profitability.
General Manager & Corporate NPS Mentor
LENSCRAFTERS
06.2012 - 08.2017
- Executive Mentorship: One of two GMs selected based on merit to work with corporate executives as an NPS Mentor, training regional managers on providing exceptional patient experiences and testing pilot-group behaviors.
- Financial Stewardship: Full P&L ownership of high-volume medical/retail operations, managing multi-million dollar annual budgets and driving regional profitability.
Senior Customer Service Manager
MICRO CENTER
06.2007 - 06.2009
- Large-Scale Operations: One of three senior managers directing operations for a $50M high-volume location, managing a massive cross-functional workforce and departmental budgets.
Senior Customer Service Manager
MICRO CENTER
06.2007 - 06.2009
- Large-Scale Operations: One of three senior managers directing operations for a $50M high-volume location, managing a massive cross-functional workforce and departmental budgets.
Sales & Installation Manager
CIRCUIT CITY
04.1995 - 05.2007
- Circle of Excellence (President’s Club): Achieved the highest tier of national recognition, awarded to the top 1% of managers for exceptional leadership and operational results.
- Innovation Test Market: Selected to participate in corporate pilot programs to develop and refine new operational innovations for nationwide scaling.
Sales & Installation Manager
CIRCUIT CITY
04.1995 - 05.2007
- Circle of Excellence (President’s Club): Achieved the highest tier of national recognition, awarded to the top 1% of managers for exceptional leadership and operational results.
- Innovation Test Market: Selected to participate in corporate pilot programs to develop and refine new operational innovations for nationwide scaling.
Education
Prerequisite and Business Coursework - undefined
Salem State College
Salem, MASkills
- Clinical trial management
- Technical calibration
- Regulatory compliance
- Workforce training
- Advanced diagnostics
- Cross-functional leadership
- P&L management
- Patient experience enhancement
- Mobile unit logistics
- Performance metrics analysis
- Certification processes
- Operational workflow design
- Risk management strategies
- Strategic planning
- Workforce management
Key Career Highlights
- Clinical Workforce Authority: Authorized Subject Matter Expert (SME) and Trainer for the MostVR (StreetLab) diagnostic platform; personally certified 15+ clinical technicians and validated specialized training environments to ensure 100% protocol adherence.
- High-Stakes Study Execution: Orchestrated field operations for major Phase II/III pharmaceutical trials, including Xenon X-TOLE and X-NOVA, maintaining a zero-deviation record across all study endpoints and data audits.
- National Operational Autonomy: Managed 100% of nationwide logistics, travel orchestration, and site-specific participant scheduling, operating with total independence across the contiguous U.S. to deliver mobile clinical services with zero downtime.
- Executive Leadership Pedigree: Recipient of the Circle of Excellence (Top 1% National Award) and selected as a corporate NPS Mentor, demonstrating a 20-year history of elite performance and staff development.
Clinical Trial Portfolio - Phase I I I I
- Neurology / CNS, Xenon X-TOLE (Focal-onset seizures), X-NOVA (MDD), NMRA-335140-301/302/501 (Major Depressive Disorder)
- Ophthalmology / Gene Therapy, AGTC-RPGR-002 (X-linked Retinitis Pigmentosa), AGTC-CNGA3-002 (Achromatopsia), LT4090-102 (Eye drops PK study)
- Rare Disease / Pulmonary, VX20-445-111 (Cystic Fibrosis), BUS-P3-01 (Refractory Chronic Cough)
- Pharmacology, EBS-SIN-001 (SIAN Nasal Spray), JNJ-89495120-1001 (Drug-drug interaction)
Technical Certifications
Good Clinical Practice (GCP), Human Subjects Research, EMMES Certified (Site & Clinician), HIPAA, MostVR Certified Trainer & Room Validator, MostVR Technician, MAIA, OPA, AVOT, OCT, Pentacam, ION Photography, Specular Microscopy, CPOA (Certified Paraoptometric Assistant), ABO (American Board of Opticianry)
Personal Information
Title: Clinical Operations Lead | National Subject Matter Expert (SME)
Certification
Clinical: Good Clinical Practice (GCP), Human Subjects Research, EMMES Certified (Site & Clinician), HIPAA.
•
Diagnostic: MostVR Certified Trainer & Room Validator, MostVR Technician, MAIA, OPA, AVOT, OCT, Pentacam, ION Photography, Specular Microscopy.
•
Professional: CPOA (Certified Paraoptometric Assistant), ABO (American Board of Opticianry).
Timeline
Clinical Operations Lead & National SME
20/20 ONSITE
02.2020 - 10.2025
Clinical Operations Lead & National SME
20/20 ONSITE
02.2020 - 10.2025
General Manager & Corporate NPS Mentor
LENSCRAFTERS
06.2012 - 08.2017
General Manager & Corporate NPS Mentor
LENSCRAFTERS
06.2012 - 08.2017
Senior Customer Service Manager
MICRO CENTER
06.2007 - 06.2009
Senior Customer Service Manager
MICRO CENTER
06.2007 - 06.2009
Sales & Installation Manager
CIRCUIT CITY
04.1995 - 05.2007
Sales & Installation Manager
CIRCUIT CITY
04.1995 - 05.2007
Prerequisite and Business Coursework - undefined
Salem State College