Lausanne, Vaud, Switzerland
Clinical research professional with 15 years experience of managing clinical trials and programs. TA experiences: Oncology, Hematology, Autoimmunity and Vaccines. Successfully managed all aspects of global Phase 1 through IV clinical trials/programs in EU, North America, APAC, including China, Japan and Australia within the defined budget and timelines. In addition to Global Program management roles, I extended my responsibility at pipeline level serving as Head of Regional Clinical Operations, working with interdisciplinary interfaces and cross functional departments. Skills: deep knowledge of clinical research regulations, (ICH, GCP, FDA, MHRA, PMDA and EMA guidelines). Strong attitude at team work and effective team builder, including working in matrix organizations.
- Therapeutic areas: Oncology. - Management of project activities and project team members. - Overall support and mentoring of Clinical Monitors involved in Oncology International protocols: from Phase I to Phase IV. - Managing study budgets; involved in training and mentoring of teams (up to 10 CRAs) in all instances related to Clinical Operations. - Good knowledge of ICH-GCP Guidelines, EU Directive and Italian regulatory requirements and Internal SOPs to handle adverse events from CTs, Spontaneous Reports and Literature cases; deep knowledge on clinical trials and on all the safety aspects related to both drugs and vaccines during the entire development process of the product (from clinical trials to the post-licensing period). - Strong competences in Clinical Development, Drug Development and Clinical Data Management. - Strong experience in Oncology and Hematology Clinical Research. - Deep knowledge of RECIST Criteria 1.1, IWRS and clinical supplies, CRF and data flow.
CRA certified according to the Italian Decree of 31st March 2008 Therapeutic Areas: Oncology, Hematology and Vaccines. Clinical Trial Competences and Skills: - Ability to contribute to Project Management team activities according to relevant Big Pharma SOPs and guidelines and regulatory requirements. - Involved in international protocols: Phase I to Phase IV and Observational Studies. - Supporting in the Project Control activities and communicates with Clinical Research Investigators.
Topic of the project: Generation of a wide range influenza virus vaccine based on the conserved hemagglutinin stalk domain (Headless hemagglutinin) using poxviral vectors MVA. Project involved in the Academic Project “No Flu ” Cariplo Research Project.