Clinical Data Analyst - Clinical Trials & Compliance

SWETHA BALAVANTHULA

******.**********@*****.***, +91-939*******

Hyderabad, India.

Dedicated Clinical Data Analyst with over 2+ years of experience managing clinical studies and

global clinical trials. Successfully ensured audit readiness for more than +70 studies and

streamlined clinical documentation processes, improving e ciency by 20% and ensured 100%

audit readiness for regulatory inspections. Pro cient in regulatory submissions, compliance

monitoring, and cross functional collaboration. Demonstrated ability to work in team-oriented and

cross functional settings.

CAREER EXPERIENCE

Thermo sher Scienti c Pvt Ltd, Toronto, Canada.

Clinical DA February 2024- June 2025

* conduct remote and on-site visits: pre-study, initiation, interim, close out, and for cause visits.

* Review informed consent, source data, adverse event tracking, and protocol deviations.

* Performed statistical analysis on top line data, identifying trends and patterns to support

evidence-based decision making.

* Collaborated with clinicians to ensure databases were set up accurately and e ciently, enabling

smooth data management processes.

* Updated SAS macros to meet evolving needs and improve data processing e ciency by 30%.

* Performed data cleaning and transformation tasks, ensuring data integrity and accuracy for

analysis.

* Providing statistical support for research projects, conducting hypothesis testing and

interpreting results.

EDUCATION

Bachelor of Pharmacy

Kakatiya University- University college of pharmaceutical sciences, Warangal, September 2015-

June 2018.

Health care administration- Sault college, September 2019- August 2020

Ontario, Canada.

Personal support worker- May 2021- April -2023

Ontario, Canada.

TECHNICAL SKILLS

Data management -

Clinical data review, EDC.

Software-

MS O ce Suite ( word, excel, power point ).

TECHNICAL PROFICIENCES

* leadership and time management

* Problem solving

* E ective communication

* Critical thinking

* Relationship management

* Attention to detail

* Stress management

Key Achievements

*streamlined clinical trial documentation processes, reducing turnaround time by 20%.

* successfully managed essential document collection for over+70 clinical studies, ensuring

100% regulatory compliance.

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* Played a pivotal role in achieving audit readiness for 30+ clinical studies, leading to successful

regulatory inspections.

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