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Gayatri XXXXX

@gayatrixxxxx

I am an experienced clinical operations leader delivering end-to-end trial execution and team mentorship.

United States
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What I'm looking for

I seek a senior clinical operations role leading end-to-end trial delivery, process improvement, team mentorship, and quality-focused execution in a collaborative organization.

I am an Associate Director–level clinical operations professional with 14 years of clinical research experience and eight years focused on trial management across CRO, site, and pharmaceutical settings. I have overseen studies across all four phases and worked with multidisciplinary teams across North America and global regions.

I have led site selection, initiation, monitoring, and close-out activities, and developed and reviewed key study documents including SOPs, informed consent forms, monitoring plans, and CRFs. I drive quality and compliance through QMS/CAPA management, vendor oversight, risk-based monitoring, and hands-on project delivery using CTMS, eTMF, EDC and eConsent platforms.

I lead and mentor clinical teams, implement process improvements, and support successful patient recruitment and study activation. I am a primary author on a peer-reviewed ecology publication and bring a detail-oriented, quality-driven approach to delivering complex trials.

Experience

Work history, roles, and key accomplishments

Premier Research logoPR

Clinical Lead III

Premier Research

Dec 2023 - May 2025 (1 year 5 months)

Led clinical management teams to activate trial sites, optimize patient recruitment and retention, and ensure timely, GCP-compliant delivery of study milestones across global projects.

PPD logoPP

Principal Clinical Team Manager

PPD

Apr 2021 - Dec 2023 (2 years 8 months)

Led North America clinical teams to deliver trials on time and in budget, implementing standardized monitoring processes and ensuring audit/inspection readiness across vaccine and infectious disease studies.

Texas State University logoTU

Research Assistant

Texas State University

Aug 2013 - Dec 2015 (2 years 4 months)

Conducted field and laboratory research including surveys, histology, data analysis, and teaching support, and authored reports to summarize research findings for academic dissemination.

LL

Regional CRA

Lambda Therapeutic Research Pvt Ltd

Jul 2012 - Jul 2013 (1 year)

Managed multiple research protocols including site identification, initiation, monitoring, and ethics submissions to support successful trial conduct in dermatology, diabetology, and general medicine.

CL

Clinical Research Associate

ClinRx Tangent Research India Pvt Ltd

Aug 2011 - Jun 2012 (10 months)

Performed site initiation, monitoring, and close-out activities while ensuring GCP compliance, informed consent processes, and accurate source data verification across clinical studies.

Education

Degrees, certifications, and relevant coursework

Texas State University logoTU

Texas State University

Master of Science, Ecology

Activities and societies: Research Assistant: conducted vegetation, bird, and small mammal surveys; histology preparation and examination; teaching and grading laboratory practicals; primary author of "Birth Mass Scaling in Elk" (The American Midland Naturalist, Jan 2016).

Master of Science in Ecology from Texas State University, San Marcos, completed in 2015.

Western Kentucky University logoWU

Western Kentucky University

Bachelor of Science, Biology

Bachelor of Science in Biology from Western Kentucky University, Bowling Green, completed in 2009.

Tech stack

Software and tools used professionally

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Gayatri XXXXX - Associate Director, Clinical Trials - Compass Pathways | Himalayas