Hi, I’m Kate Nikishina. I’m a detail-oriented quality-control professional with 12+ years of experience in international projects, focusing on data accuracy, documentation management, and strict regulatory compliance. I excel at reviewing large datasets, maintaining data integrity, and creating structured processes that keep records consistent across teams in different countries. I’ve supported remote teams across multiple time zones and am proficient in MS Excel, data handling, and digital record systems like Veeva Vault and SharePoint. I’m comfortable raising queries when guidelines are unclear and turning complex datasets into reliable, auditable documentation.

Kate Nikishina

Hi, I’m Kate Nikishina. I’m a detail-oriented quality-control professional with 12+ years of experience in international projects, focusing on data accuracy, documentation management, and strict regulatory compliance. I excel at reviewing large datasets, maintaining data integrity, and creating structured processes that keep records consistent across teams in different countries. I’ve supported remote teams across multiple time zones and am proficient in MS Excel, data handling, and digital record systems like Veeva Vault and SharePoint. I’m comfortable raising queries when guidelines are unclear and turning complex datasets into reliable, auditable documentation.

Available to hire

Hi, I’m Kate Nikishina. I’m a detail-oriented quality-control professional with 12+ years of experience in international projects, focusing on data accuracy, documentation management, and strict regulatory compliance. I excel at reviewing large datasets, maintaining data integrity, and creating structured processes that keep records consistent across teams in different countries.

I’ve supported remote teams across multiple time zones and am proficient in MS Excel, data handling, and digital record systems like Veeva Vault and SharePoint. I’m comfortable raising queries when guidelines are unclear and turning complex datasets into reliable, auditable documentation.

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Language

English
Fluent
Russian
Fluent

Work Experience

Start-Up Lead & eTMF Quality Control Specialist, Project Associate III at ICON plc (on behalf of Bayer)
November 1, 2023 - November 1, 2023
Conducted detailed quality checks on large volumes of clinical documentation, identifying errors and inconsistencies. Ensured data integrity by validating accuracy against regulatory standards. Created structured templates to improve consistency of records across countries. Supported international teams remotely, resolving queries and aligning processes.
Study Start-Up Associate / Clinical Trial Assistant at Premier Research
January 1, 2014 - January 1, 2014
Coordinated documentation and performed detailed accuracy checks for trial submissions. Maintained structured records and supported reporting requirements.
Study Start-Up Associate / Clinical Trial Assistant at Premier Research
December 31, 2014 - December 31, 2014
Coordinated documentation and performed detailed accuracy checks for trial submissions. Maintained structured records and supported reporting requirements.

Education

University Degree (Master’s level, UK ENIC) at Moscow
January 1, 1988 - November 6, 2025
University Degree (equivalent to Master’s level, UK ENIC) at Moscow
January 11, 2030 - January 1, 1988
University Degree (equivalent to Master’s level, UK ENIC) at Moscow
January 11, 2030 - January 1, 1988
University Degree (equivalent to Master’s level) at Moscow
January 11, 2030 - January 1, 1988

Qualifications

Data Integrity & Quality Control
January 11, 2030 - November 6, 2025
GCP
January 11, 2030 - November 6, 2025
Informed Consent
January 11, 2030 - November 6, 2025
UK Policy Framework
January 11, 2030 - November 6, 2025
Data Integrity & Quality Control
January 11, 2030 - November 6, 2025
GCP (Good Clinical Practice)
January 11, 2030 - November 6, 2025
Informed Consent
January 11, 2030 - November 6, 2025
UK Policy Framework
January 11, 2030 - November 6, 2025
Data Integrity & Quality Control
January 11, 2030 - November 6, 2025
GCP
January 11, 2030 - November 6, 2025
Informed Consent
January 11, 2030 - November 6, 2025
UK Policy Framework
January 11, 2030 - November 6, 2025
Data Integrity & Quality Control
January 11, 2030 - November 6, 2025
GCP
January 11, 2030 - November 6, 2025
Informed Consent
January 11, 2030 - November 6, 2025
UK Policy Framework
January 11, 2030 - November 6, 2025

Industry Experience

Healthcare, Life Sciences, Professional Services, Software & Internet, Education