Lindsey Ellis
Austin,TX
Summary
Clinical operations leader with over 10 years of experience in global clinical trial execution across site management and cross-functional teams. Proven ability to drive operational excellence, ensure inspection readiness, and support end-to-end trial delivery from site activation through closeout. Skilled in stakeholder engagement, risk mitigation, and regulatory compliance across multi-site studies.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Senior Site Manager – Global Clinical Operations
Johnson & Johnson Innovative Medicine
01.2018 - Current
- Led site management teams as Lead Site Manager across multiple studies, ensuring alignment between local and central teams, improving communication flows, and strengthening execution across study operations.
- Co-developed and helped drive an Enhanced Site Engagement Initiative, targeting high-priority sites to improve engagement, identify operational friction points, and enhance overall study performance.
- Lead operational oversight of multiple clinical trial sites across therapeutic areas including Neurology, Mood Disorders, Vaccine, and Immunology.
- Drive site performance, protocol compliance, and patient safety across the study lifecycle while ensuring inspection readiness through audit support, documentation review, and GCP adherence.
- Partner with cross-functional teams, including LTMs, CRAs, Medical, and Regulatory, to advance study milestones and oversee site activation, enrollment, monitoring support, and closeout activities.
- Provide training and onboarding for site staff and study teams while supporting risk management and issue resolution to maintain study timelines.
Clinical Research Associate II
Syneos Health
01.2016 - 01.2018
- Advanced from CRA to CRA II while supporting Phase I–IV studies, audit readiness, site performance management, and operational execution across monitoring activities.
Senior Clinical Research Coordinator
FutureSearch Trials of Neurology
01.2014 - 01.2016
- Led study coordination and startup activities, including training, regulatory submissions, and source documentation processes to support efficient site operations.
Research Coordinator
UTHealth Science Center at Houston
01.2012 - 01.2014
- Managed day-to-day research operations, staff training, participant workflows, and multi-site study coordination to support execution quality and timeline adherence.
Clinical Student Intern
Shriners Hospitals for Children
01.2012 - 01.2012
- Delivered behavioral health assessments and coordinated multidisciplinary treatment support for pediatric and family populations in a complex clinical care setting.
Graduate Student Clinician
Psychological Services Clinic
01.2011 - 01.2011
- Provided psychotherapy support, behavioral assessments, and clinical documentation while applying evidence-based approaches across diverse patient needs.
Clinical Office Manager
Shiloh Treatment Center
01.2008 - 01.2011
- Oversaw office operations, staff coordination, and process improvements in a high-acuity care setting, building early leadership experience in compliance-driven environments.
Education
Master of Arts - Clinical Psychology
University of Houston–Clear Lake
2012
Bachelor of Arts - Psychology
SUNY–University At Buffalo
2008
Skills
- Clinical operations leadership across global Phase II–IV trials, including site management, oversight, and end-to-end study execution
- Inspection readiness, regulatory compliance, and quality oversight, including FDA/EMA readiness, SOP/GCP adherence, and data quality through study closeout
- Cross-functional and stakeholder collaboration, partnering with Medical, QA, Regulatory, vendors, and internal teams to drive execution and resolve issues
- Team leadership, training, and risk management, with experience in mentorship, issue escalation, and operational support across complex studies
Certification
- CCRA, ACRP
Timeline
Senior Site Manager – Global Clinical Operations
Johnson & Johnson Innovative Medicine
01.2018 - Current
Clinical Research Associate II
Syneos Health
01.2016 - 01.2018
Senior Clinical Research Coordinator
FutureSearch Trials of Neurology
01.2014 - 01.2016
Research Coordinator
UTHealth Science Center at Houston
01.2012 - 01.2014
Clinical Student Intern
Shriners Hospitals for Children
01.2012 - 01.2012
Graduate Student Clinician
Psychological Services Clinic
01.2011 - 01.2011
Clinical Office Manager
Shiloh Treatment Center
01.2008 - 01.2011
Master of Arts - Clinical Psychology
University of Houston–Clear Lake
Bachelor of Arts - Psychology
SUNY–University At Buffalo