Ashna T
Project Technician at ICMR NIV> Clinical Research Professional | Clinical Trial Management | Pharmacovigilance & Drug Safety | Medical Writing | Clinical Data Management | APCRM
- Role
- Internship Trainee at Clini India
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Ashna T
I am a life sciences professional currently pursued the Advanced Programme in Clinical…
Experience
Internship Trainee
Apr 2025 — Present · Bengaluru, IN
Clinical Trial Management Complete understanding of GCP principles, clinical study design, and protocol development Knowledge of investigator responsibilities, site feasibility, site management, trial monitoring, and auditing Experience in data collection, statistical analysis, reporting, and clinical trial safety & risk management Solid foundation in ethics committee coordination, regulatory affairs, and compliance-Clinical Data Management Proficiency in developing Data Management Plans (DMPs) and using Electronic Data Capture (EDC) systems Knowledge in data validation, query management, CRF design & development, data coding and dictionary management Skilled in ensuring data accuracy, integrity, and following CDM standards & guidelines during analysis and reporting-Pharmacovigilance / Drug Safety Familiarity with global PV regulations and guidelines for adverse drug reaction (ADR) reporting & case processing Knowledge in signal detection, benefit–risk evaluation, safety data exchange agreements, and PV audits & inspections Awareness of emerging trends and technology in pharmacovigilance-Medical Writing Experience in regulatory medical writing, scientific publications, abstracts, and posters Skilled in manuscript preparation, review, editing, and publication ethics Competence in writing patient information leaflets, investigator brochures, protocols, and safety narratives
Education
Periyar University
Master's degree, Microbiology, General
2020 — 2022
University of Calicut
Bachelor's degree, Biotechnology
Govt Model Higher Secondary School, Calicut
Higher Secondary, Science
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