Gayatri XXXXX
@gayatrixxxxx
I am an experienced clinical operations leader delivering end-to-end trial execution and team mentorship.
What I'm looking for
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
Associate Director, Clinical Trials
Compass Pathways
May 2025 - Present (4 months)
Oversee operational execution of clinical trials, ensuring adherence to timelines, budget, and quality standards while leading clinical operations and vendor relationships to support delivery of mental health therapies.
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.
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.
Managed overall conduct of bioavailability and bioequivalence studies, coordinating cross-functional teams to meet timelines, maintain profitability, and ensure regulatory-compliant study execution.
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.
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.
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.
Clinical Research Associate
Micro Therapeutics Research Labs Pvt Ltd
Feb 2010 - Aug 2011 (1 year 6 months)
Maintained regulatory study files, conducted monitoring visits, and supported CRF development and compliance activities to ensure protocol adherence and data integrity.
Education
Degrees, certifications, and relevant coursework
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
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
Availability
Location
Authorized to work in
Job categories
Skills
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