Ansharah Ahmed

Directed remote PSVs and SIVs for 4–7 concurrent sites across neurology, dermatology, and oncology studies, ensuring on-time site activation and readiness. Managed end-to-end startup documentation workflows including CDA/NDA execution, IRB/EC submissions, and regulatory package tracking.

Executed remote monitoring visits and conducted source data verification (SDV) in alignment with sponsor monitoring plans. Tracked protocol deviations, generated monitoring visit reports, and escalated findings to study management within defined timelines.

Supported site identification, outreach, and feasibility assessments for dermatology and neurology indications. Coordinated sponsor communications and maintained tracking systems for site qualification pipelines.

Monitored polio vaccination teams across field sites ensuring cold chain compliance, proper administration, and adherence to WHO SOPs. Conducted independent community surveys with household-level validation and daily gap reporting using designated monitoring tools.

Supported site in executing the Livzon Booster Vaccine trial: assisted in participant recruitment documentation and compliance oversight. Monitored patient progress, coordinated source document collection, and archived clinical trial data per ICH-GCP guidelines.

Conducted experimental research including algal culture maintenance, statistical data analysis (DOE, growth curve studies), and spectroscopy. Developed registered industrial design for an algae-based bioreactor (IPO-Pakistan, Design No. 22571-D, Class 24).

Pursued a BS in Biotechnology, completing a thesis on secondary metabolites from mangrove-associated fungi.