About
Master’s degree in Biotechnology and foundational knowledge in clinical data management, data review, and regulatory compliance. Skilled in supporting clinical data cleaning, discrepancy management, query resolution, and EDC system operations. Familiar with ICH–GCP guidelines, SOPs, TMF documentation, and ALCOA+ data integrity principles. Highly detail-oriented, analytical, and eager to contribute to accurate, high-quality clinical trial data management in Life Sciences R&D.
Skills & Expertise (23)
Work Experience
Quality Assurance Trainee
Biological .E limited
Present - Present
Support clinical data review and data cleaning activities. Identify data discrepancies and assist in query generation and resolution. Perform data entry and data validation in Clinical EDC systems. Assist in maintaining CRF Completion Guidelines (CCG) and study-related documentation. Support SAE reconciliation and protocol deviation tracking. Assist in edit check testing and basic database validation activities. Support User Acceptance Testing (UAT) of clinical databases. Assist in preparation and review of clinical data listings and reports. Ensure compliance with GCP, SOPs, and regulatory guidelines during all activities. Collaborate with cross-functional teams to meet study timelines and quality standards.
Education
Master in Biotechnology (Integrated) - ANNAMALAI UNIVERSITY
- 2025 · Afghanistan
HSC - SUBRAMANIA BHARATHI HIGHER SECONDARY SCHOOL
- 2020 · Afghanistan
SSCL - SUBRAMANIA BHARATHI HIGHER SECONDARY SCHOOL
- 2018 · Afghanistan
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Relocation
Open to Relocation
