Antoniya Tasheva
Sofia,Bulgaria
Summary
Experienced clinical research professional with 9+ years supporting complex international clinical trials, with strong focus on clinical data review, query management, and data quality oversight. Proven ability to support data management activities, ensuring the delivery of high- quality clinical data in compliance with GCP, protocols, SOPs, and regulatory standards. Skilled in data analysis, discrepancy, identification, query generation and resolution, and collaboration with cross-functional teams to ensure timely database cleaning and readiness for database lock. Experienced in EDC systems, RBM analytics, and clinical data lifecycle process, contributing to efficient and compliant study execution.
Overview
10
10
years of professional experience
6
6
years of post-secondary education
Work history
Clinical Data Risk Analyst
ICON Plc
Sofia, Bulgaria
2024.11 - Current
- Perform centralized clinical data review using RBM tools (CLuePoints) identifying trends, inconsistencies and potential data quality issues.
- Support query generation and resolution activities by identifying problematic, missing or inconsistent data.
- Analyze aggregated datasets and risk indicators to support clinical data review.
- Contribute to data review strategy development and monitoring approaches
- Collaborated closely with cross-functional teams for comprehensive evaluation of operational risks.
Senior clinical research associate
IQVIA
Sofia, Bulgaria
2017.10 - 2024.11
- Conduct systemic review of clinical trial data and eCRF to ensure accuracy, completeness and consistency;
- Generated, tracked and resolved data queries in collaboration with sites and data management teams.
- Performed data verification and discrepancy identification, supporting high-quality data delivery
- Ensure Compliance with Monitoring plan, protocol requirements, SOPs, and GCP standards.
- Monitored CRF completion, data entry timelines and query resolution metrics.
Clinical research assistant
IQVIA
Sofia, Bulgaria
2016.10 - 2017.10
Education
Bachelor of Science - Biotechnology
University Prof. Asen Zlatarov - Bulgaria
Burgas 2008.09 - 2012.09
Master of Science -
Aalborg University Copenhagen
Denmark 2013.09 - 2015.09
Skills
- Clinical Data Review & Query resolution
- Data Quality Oversight & Data Integrity
- GCP & Regulatory Compliance
- EDC System & eCRF Review
- Data Reconciliation & Listings Review
- Risk-Based Monitoring Analytics
- Protocol and SOP adherence
- Issue Management & CAPA Awareness
- Cross- Functional Collaboration
- Regulatory submission support
Accomplishments
FSP Above and Beyond Award, 2019
Timeline
Clinical Data Risk Analyst
ICON Plc
2024.11 - Current
Senior clinical research associate
IQVIA
2017.10 - 2024.11
Clinical research assistant
IQVIA
2016.10 - 2017.10
Master of Science -
Aalborg University Copenhagen
2013.09 - 2015.09
Bachelor of Science - Biotechnology
University Prof. Asen Zlatarov - Bulgaria
2008.09 - 2012.09