Madhu Hota

I’m a results-driven Senior Project Administrator with 5+ years of progressive experience in MSc in Applied Microbiology, clinical research, and pharmaceutical project operations. I focus on Trial Master File (TMF) management, cross-functional coordination, and regulatory-compliant execution in fast-paced, GCP/ICH-regulated environments.

I’ve supported end-to-end management of Trial Master File (TMF) documentation—ensuring accuracy, completeness, compliance, and audit readiness throughout the study lifecycle. I’m recognized for streamlining project workflows and driving operational efficiency within CRO environments.

In my current work with PremierResearch, I co-manage study tracking activities, manage project system access provisioning, maintain site contact databases, and support study communication workflows with Project Specialists and Senior Project Specialists. I also handle key study operations such as ISF packages, training matrices, SOP indexes, distribution lists, and documentation completeness.

I’ve coordinated functional deliverables, milestones, and study activities through effective Master Project Management collaboration, including vendor management activities tied to study supplies, invoices, budgets, and pass-through costs. With experience across oncology and CNS therapeutic studies, I maintain clear stakeholder communication across sponsors, eTMF leads, CTMS/Veeva Vault/SharePoint, and site personnel to support inspection readiness.