Ashifa Shirin
Site Start-up | Regulatory | eTMF | Clinical Documentation | Data Management | Clinical Operations| Feasibility Studies|
- Role
- Clinical Study Administrator at AstraZeneca
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Ashifa Shirin
Trailblazing Clinical Study Administrator with a global perspective and a knack for transforming trial operations into seamless, high-impact experiences. Blending rigorous project management with creative problem-solving, I leverage cutting-edge digital tools and data visualization to elevate trial quality, optimize workflows, and empower cross-functional teams. Recognized for not just meeting deadlines—but for anticipating risks, inventing solutions, and translating complexity into clarity. My passion for clinical research drives collaboration, bold thinking, and meticulous oversight, delivering results that advance both patient outcomes and organizational excellence. Ready to bring vision, agility, and originality to a forward-thinking clinical trial team.
Experience
Clinical Study Administrator
Feb 2023 — Present · Bengaluru, IN
Coordinated and administered clinical study activities from start-up to closeout, ensuring quality and consistency.• Collected, prepared, reviewed, and tracked documents for the application process, ensuring timely submission to EC/IRB and regulatory authorities.• Liaised with Investigators, external service providers, and CRAs to support effective delivery of study documents.• Maintained and tracked essential documents in the eTMF and ISF, ensuring compliance with ICH GCP and local requirements.• Ensured inspection readiness of the eTMF and supported closeout activities for the ISF.• Contributed to the production and maintenance of study documents, ensuring template and version compliance.• Hands on Experience in Power BI Tools to analyze & interpret Study TMF Metrices.• Handled & coordinated Global Shipments/Documentations of Trial Supplies including Lab Kits & ePRO Devices.• Provided administrative support to the Site Staff with Trial Supplies & Documentation requirements.
Education
INDIAN ACADEMY GROUP OF INSTITUTIONS
Masters of Science, Biotechnology
2019 — 2021
Guru Ghasidas University
Bachelor of Science, Biotechnology
2016 — 2019
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