Dr. Basia Hofmann

Leads protocol optimization and study feasibilities for multinational clinical studies Develops strategic recommendations based on data Conducts investigator interviews, patient insights for trial design feedback Conducts comprehensive feasibility assessments Forecasts patient enrolment using recruitment modelling tools Leads virtual teams and fosters communication Develops electronic surveys Provides training to internal clinical teams Cooperates with CROs for joined feasibilities

Managing international Phase II-III & CRO-driven clinical trials particular in oncology & cardiovascular diseases Leading global and cross-functional study teams Overseeing end to end study-related activities Preparing protocol & documents Tracking & reporting of study performance with tools Developing & tracking the study budget Identifying study risks, assessing their impact, & implementing mitigation strategies Collaborating with international leaders Managing external vendors and quality

Managing international PhII-III trials in Germany Overseeing trial processes, timelines, budgets Conducting monitoring visits, compiling reports Developing enrolment, risk management strategies, contingencies Ensuring trial compliance, inspection readiness Handling regulatory submissions, EC interaction Resolving compliance issues, maintaining CAPAs Leading study teams, training CRAs Collaborating with verious internal departments Ensuring trial master file’s quality Primary contact for CRO-driven studies

Institute for Medical Microbiology Degree: ”Magna cum claude” Subject:” Epidemiology, detection and typing as well as examinations from virulence and resistance mechanism of methicillin-resistant Staphylococcus aureus-strains

Subject: Investigations on protein transport in gram-positive and gram-negative bacteria”

Education and examination