Open to opportunities

Sumathi User

@sumathiuser

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I analyze clinical trial data and strengthen study quality, compliance, and regulatory readiness.

United States

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What I'm looking for

I'm looking to apply clinical data analysis, site monitoring, ICH-GCP compliance, and scientific research experience to strengthen trial quality, endpoint review, regulatory readiness, and evidence generation.

At Artivion, I analyze longitudinal PERSEVERE US IDE data, reconcile EDC queries and safety documentation, and coordinate endpoint reviews across clinical, medical, data management, and regulatory teams.

I validate datasets and translate mortality, survival, and safety findings into decision-ready tables, narratives, and benefit-risk summaries. My work has improved clinical-data review efficiency by 18%, reduced endpoint discrepancy-resolution turnaround by 22%, and improved study-file completeness by 16%.

Previously at Worldwide Clinical Trials, I managed monitoring across 12 sites for a Phase III cardiovascular-metabolic study, using risk-based monitoring, source-data verification, CTMS, and eTMF workflows to protect data integrity and ICH-GCP compliance.

My foundation in life sciences includes research at Syngene International supporting Baxter renal therapy and parenteral nutrition development, plus longitudinal diabetes research at Madras Diabetes Research Foundation. I bring 12+ years spanning clinical research, statistical analysis, molecular and biochemical methods, scientific writing, publications, peer review, and research mentorship.

Experience

Work history, roles, and key accomplishments

Current

Clinical Research Analyst

Current

Artivion, Inc.

Jul 2024 - Present (2 years 2 months)

Analyzed longitudinal PERSEVERE US IDE data across 93 participants, improving clinical-data review efficiency by 18%. Reconciled EDC queries, adverse events, and protocol deviations to strengthen data integrity and ICH-GCP compliance.

Clinical Data Analysis EDC CTMS ICH GCP Statistical Analysis Data Validation Query Management ETMF Adverse Event Reporting Protocol Compliance

Clinical Research Associate

Worldwide Clinical Trials

Sep 2020 - Jun 2024 (3 years 9 months)

Managed monitoring activities across 12 sites for a Phase III cardiovascular-metabolic study. Performed risk-based monitoring and source-data verification, accelerating data-query resolution by 18% and streamlining monitoring-report turnaround by 22%.

Site Monitoring Risk Based Monitoring Source Documentation Verification (SDV)EDC CTMS ICH GCP ETMF Protocol Compliance Data Cleaning Query Management

Research Scientist

Syngene International

Jan 2013 - Dec 2015 (2 years 11 months)

Executed launch-stage research within Baxter's Global Research Center, supporting renal therapy and parenteral nutrition development. Enhanced analytical repeatability by 16% and minimized repeat testing by 14% through standardized procedures and root-cause investigations.

Experimental Design UV Vis Spectroscopy FTIR GC MS Statistical Analysis Formulation Product Characterization Technical Writer Data Analysis

Postdoctoral Research Fellow

Madras Diabetes Research Foundation

Sep 2009 - Aug 2012 (2 years 11 months)

Examined CURES follow-up data from 20,000+ participants, evaluating biochemical and metabolic indicators associated with diabetes and cardiovascular risk. Standardized laboratory procedures and contributed to the 10-year follow-up framework.

Biochemistry Statistical Analysis Data Analysis Electrophoresis Protein Assays Research Documentation Mentorship Scientific Writing

Education

Degrees, certifications, and relevant coursework

Bharathiar University

PhD, Life Science

2006 - 2009

Pursued a PhD in Life Science with a focus on endocrine biochemistry, conducting research on metabolic and biochemical aspects related to diabetes and related complications.

Bharathiar University

M.Phil., Life Science

2003 - 2005

Completed M.Phil. in Life Science with a specialization in endocrine biochemistry, involving advanced study and research in biochemical and metabolic processes.