International Clinical trial expertise in Oncology (Canada, EU, Israel, USA): personalized trials, including Phase 1 & 2, omics, molecular tumor bord and validation of algorithms for treatment efficacy prediction.Contributes to the development of protocols and budgets. Reviews contracts, selects and oversees vendors. Plans and organizes study logistic.Responsible for regulatory submissions (FDA & EU) and responses. Authors and manages approval of informed consent documents and other patient’s materials.Reviews, reports and manages protocol deviations. Prepares protocol amendments.Ensures operational efficiency, trial quality and compliance: performs risk assessment, authors essential clinical study documents (e.g. CRF, functional plans, study manuals). Inputs, reviews and approves other documents (e.g. safety management, reconciliation and data management plans). Manages clinical execution according to plans and operational/clinical issues in a timely manner. Acts as primary contact support for the project team and all clinical sites.Sets up site feasibility, reviews and approves site selection. Conducts site initiation visits, monitoring and audits. Reviews safety data, SAE and expedited reports and reconciliations. Inputs and reviews DSURs. Coordinates clinical monitoring committee meetings.Participates in data review and analysis, providing tables, figures, listings for publication of results in peer-reviewed journals. Prepares and reviews study reports as well as presentations and posters for international meetings.Leads the data management team.Designs and coordinates the development of a new EDC system including feature specifications and regulatory compliance.Sets up the QMS to maintain compliance with international regulations and ICH/GCP (Quality Manual, Policies, SOPs, guidelines, templates).Conducts regulatory and quality surveys, and performs continuous training for professional development.

Expertise in multicenter international clinical studies in Oncology (Phase 1, 2 & 3), in particular personalized medicine and childhood malignancies.