Alessandra Borbone
Clinical Research Manager @TFS HealthScience
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WORK HISTORY
Clinical Research Manager @TFS HealthScience
Roma, IT
EDUCATION
University of Camerino
Doctor of Pharmacy - PharmD, Pharmaceutical
Università LUMSA
Master of Business Administration - EMBA
ABOUT ALESSANDRA BORBONE
With 17 years of experience in the global clinical research industry, I have built a career defined by operational excellence and high-impact leadership. My background includes 9 years in senior management roles (Clinical Operations Manager and Global Clinical Trial Manager) within leading global CRO.Leadership & Global Reach- Team Management: As COM, I managed up to 20 direct reports (CRAs and Lead CRAs/CTMs) across Italy, Spain, and the UK- Global Oversight: As Global CTM, I led cross-functional teams (Clinical Leads, CRAs, CMAs) across EMEA, NA, and APAC- Quality Excellence: I served as Clinical Quality Evaluation Team Lead for EMEA, ensuring the highest standards of compliance and audit readiness.Therapeutic Expertise: I have a strong and consistent focus on Oncology (Solid Tumors, Breast, and Ovarian Cancer), with extensive hands-on leadership in Phase II and studies. My expertise also spans Hematology, Ophthalmology, Cardiology and Neurology, among other areas.Strategic Evolution (MBA & Innovation): Currently, I am completing an MBA to bridge my scientific background (PharmD) with advanced strategic and financial frameworks. I am actively focusing on the \"Next-Generation\" of clinical trials, preparing to lead organizations through the transition to- ICH-GCP E6(R3) Standards: Aligning quality systems with the 2026 regulatory updates- Risk-Based Quality Management (RBQM): Enhancing efficiency through data-driven oversight and proactive issue resolution- Clinical Innovation: Exploring the strategic integration of AI-driven solutions and Decentralized Clinical Trials (DCT) to optimize trial delivery and patient engagement.Mindset: I am adept at guiding complex, fast-paced trials under high pressure, meeting tight deadlines with a strong sense of urgency. My leadership style is defined by professionalism, determination, and a problem-solving attitude.Location: Based in Rome (available for remote and hybrid work and for business travel as needed. Open to evaluate potential relocation).
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