Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Timeline
Generic

Chelssa Maria Sivi

Associate Clinical Data Analyst
Thrissur

Summary

Associate Clinical Data Analyst with experience across study startup, conduct, and closeout phases, and strong proficiency in Electronic Data Capture (EDC) systems. An excellent team player with leadership qualities, eager to expand skills, contribute to impactful projects, and advance my career in the clinical data management industry.

Overview

2
2
years of professional experience
2
2
Certifications
2
2
Languages

Work History

Associate Clinical Data Analyst

Fortrea
10.2024 - Current
  • Performed core data management activities such as DM review, query management, SAS and manual listings, weekly report generation, local lab reconciliation and execution of data freeze and hard lock processes during critical timelines."
  • Enhanced data quality accuracy by conducting thorough data analysis and interpretation.
  • Collaborated with cross-functional teams to ensure timely delivery of accurate, high-quality study specific data reports.
  • Established strong relationships with internal stakeholders such as project leads, associates and programmers for seamless collaboration on projects.

Assistant Clinical Data Analyst

Fortrea
06.2024 - 10.2024
  • Assist core data management tasks including data review, query management and data freeze.
  • Maintain accurate and systematic documentation of all performed activities.
  • Enhanced data accuracy in day-to-day tasks through thorough validation processes and quality control measures.

Assistant Validation

Fortrea
09.2023 - 06.2024
  • Designated as the UAT Validation Lead for over 10 studies, ensuring successful testing before the study is released to production.
  • Perform UAT activities which includes test script creation based on ALS, data entry, validation, vendor reconciliation and documentation.
  • Maintain and adhere to strict timelines for study deliverables.
  • Established strong cross-functional relationships with programmers and onshore leads to effectively troubleshoot and resolve technical issues.
  • Demonstrated consistent compliance with daily tasks and assigned trainings.


Assistant Validation Intern

LabCorp
02.2023 - 09.2023
  • Perform UAT activities which includes test script creation based on ALS, data entry and documentation.
  • Demonstrated consistent compliance with daily tasks and assigned trainings.

Education

Master of Science - Biotechnology

Vellore Institute of Technology
Tamil Nadu, India
04.2001 -

Bachelor of Science - Biotechnology

Amrita School of Biotechnology
Kerala, India
04.2001 -

AISSCE -

Devamatha CMI Public School
Kerala, India
04.2001 -

AISSE -

Indian School Darsait
Muscat, Oman
04.2001 -

Skills

  • Electronic Data Capture (EDC) systems (Medidata Rave, Veeva, Viedoc)
  • Regulatory compliance (ICH-GCP guidelines)
  • Microsoft Excel
  • Quick learner
  • Attention to detail
  • Team player
  • Communication skills

Certification

Introduction to the Biology of Cancer - Coursera

Accomplishments

Review article publication: Title - An Overview of Herbal Nutraceuticals, Their Extraction, Formulation, Therapeutic Effects and Potential Toxicity (Journal - Separations)

Timeline

Associate Clinical Data Analyst

Fortrea
10.2024 - Current

Assistant Clinical Data Analyst

Fortrea
06.2024 - 10.2024

Assistant Validation

Fortrea
09.2023 - 06.2024

Assistant Validation Intern

LabCorp
02.2023 - 09.2023

Understanding Cancer Metastasis - Coursera

09-2021

Introduction to the Biology of Cancer - Coursera

08-2021

Master of Science - Biotechnology

Vellore Institute of Technology
04.2001 -

Bachelor of Science - Biotechnology

Amrita School of Biotechnology
04.2001 -

AISSCE -

Devamatha CMI Public School
04.2001 -

AISSE -

Indian School Darsait
04.2001 -

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Chelssa Maria SiviAssociate Clinical Data Analyst