Summary
Overview
Work History
Education
Skills
Languages
Place
Personal Information
Hobbies and Interests
Disclaimer
Additional Qualifications
Timeline
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SHREEPATHI K U

SHREEPATHI K U

Bengaluru

Summary

Accomplished data standardization expert with a proven track record at PointCross Life Sciences, specializing in regulatory compliance and quality control. Skilled in CDISC standards and project management, I excel in leading teams to achieve SEND compliance and enhance data integrity, ensuring successful audits and traceability in biopharmaceutical projects.

Overview

7
7
years of professional experience

Work History

Senior member of Data standardization staff

PointCross Life Sciences
03.2020 - Current
  • Data Standardization & SEND Datasets: Led the creation, standardization, and maintenance of SEND datasets for non-clinical studies. Managed metadata storage for traceability and audits.
  • Regulatory Compliance: Validated SEND datasets against FDA, CDISC, and other regulatory standards using Pinnacle21 and eDV.
  • Quality Control & SEND Compliance: Conducted QC checks through the reconciliation process and ensured SEND compliance using the SEND-Assure process.
  • Entrada Project Management: Oversaw Entrada project management, including interim study monitoring, and business analysis.

Project Assistant

Institute of Wood Science and Technology (IWST)
12.2018 - 11.2019
  • PROJECT TITLE: comparative study on wood growth, quality and financial returns of the teak managed under different agroforestry practices in Karnataka.
  • Carrying out different physical tests
  • Carrying out different mechanical tests

Education

Master of Science - Biotechnology

Ramaiah college of Arts, science and commerce
Bengaluru, Karnataka
01.2018

Bachelor of Science - Biotechnology, Biochemistry, Genetics

Seshadripuram first grade college
Bengaluru, Karnataka
01.2016

P.U.C. - undefined

Seshadripuram Pre-University college
Bengaluru
01.2013

S.S.L.C. - undefined

Government High School
Yelahanka, Bengaluru
01.2011

Skills

  • Data Standardization
  • CDISC Standards (SDTM, SEND, Control Terminology)
  • Regulatory Validation
  • ECTD
  • Definexml
  • NSDRG
  • Pinnacle21
  • EDV

Languages

English
Kannada
Hindi
Malayalam

Place

Bengaluru, Karnataka

Personal Information

  • Date of Birth: 03/12/95
  • Gender: Male
  • Nationality: Indian
  • Marital Status: Unmarried

Hobbies and Interests

  • Cricket
  • Reading
  • Travelling
  • Photography

Disclaimer

I hereby declare that the above information provided by me is factually correct to the best of my knowledge and belief. If given a chance, I will try my level best to come true to your aspirations.

Additional Qualifications

MSc Research: Evolution of antibiotic resistance in bacteria under selection pressure

Timeline

Senior member of Data standardization staff

PointCross Life Sciences
03.2020 - Current

Project Assistant

Institute of Wood Science and Technology (IWST)
12.2018 - 11.2019

Bachelor of Science - Biotechnology, Biochemistry, Genetics

Seshadripuram first grade college

P.U.C. - undefined

Seshadripuram Pre-University college

S.S.L.C. - undefined

Government High School

Master of Science - Biotechnology

Ramaiah college of Arts, science and commerce

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SHREEPATHI K U