Rome, Latium, Italy
Experienced Project Manager with a demonstrated history of working in the biotechnology and health industry.
I provide scientific and operational consulting across RWE, clinical studies, and evidence-generation projects for academic institutions, CROs, and pharmaceutical clients. My work includes study and project management, scientific writing, systematic literature reviews, data analysis, and AI testing and evaluation to support data-driven decision-making and high-quality project delivery.
Sponsor-dedicated/FSP Clinical Study Manager, with responsibility for the operational delivery of global clinical and RWE studies. I provided end-to-end study management, including CRO and vendor oversight, study planning, risk management, metrics review, budget monitoring, and escalation management, ensuring quality, compliance, and continuity across study activities.
Managed scientific studies and evidence-generation projects from proposal development through final delivery, ensuring timelines, quality, and stakeholder alignment. Responsibilities included scientific proposal writing, protocol and medical writing, tender preparation, project and vendor management, risk assessment and mitigation planning, data analysis, systematic literature reviews, database development, and preparation of final scientific dossiers and dissemination materials.
Managed operational aspects of clinical trials in psoriasis from study start-up, ensuring compliance with GCP and relevant SOPs. Led project team meetings, supported interactions with health authorities, contributed to synopsis development and protocol review, participated in Clinical Study Report preparation, and reviewed statistical analysis plans and mock outputs to support clinical writing.
Supported Medical Advisors and Scientific Project Managers within the Special Care and Rare Diseases unit, contributing to clinical studies, study synopses, protocols, product dossiers, and clinical summaries in Rare Diseases and Neonatology. Responsibilities also included CRO oversight for RWE studies, development of training materials for MSLs and healthcare professionals, support for product management and market access through scientific content development, adaptation of protocols and procedures in line with GCP and internal requirements, preparation of congress materials, medical writing, competitive intelligence, and KOL mapping.