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I'm in charge of coordinating the transition of GeneQuine’s gene therapy drug candidates’ pipeline from pre-clinical development to Phase I clinical trials.More in details i'm involved in CRO selection and qualification as well as in PD & PK studies protocol redaction, data analysis and reporting. Coordination of GQ activities is part of my daily work.

Manage the transition of the GQ-303 development program from pre-clinical to clinical stage. Coordinate, plan, monitor and manage all development task related to the project, specially those subcontracted to external CRO.

My responsibility span on various fields:- Being the privileged interface between clients and project team- Installing and leading the dedicated multi-function team, Technology Transfer, GMP Production and QC- Managing the project in the most efficient way with special care to cost and timelines- Establishment of quotes, contract and invoices- Updating and follow up of the Life Science BU pipeline - Project Budget follow up

Responsible of the international randomized and double blind study PREOB®-ON3 – A bone cell therapy for hip osteonecrosis - NCT01529008Project responsibilities include:- CRF design, development and follow up- Management of DM activities in order to clean the database- Regulatory EC submissions- Compliance with local regulations related to cell therapy- CRO management (Imaging, Data Management, Statistics, CRF, Monitoring, Safety)- Site contracting - Relationship with investigators- Direct support for the investigating site staff, in collaboration with the assigned CRA- 4 people team managment

Responsible to coordinate the study team for achieving project objectives.Project Related Responsibility:•Set the study timelines with the team to achievable goals•Participate in project development, protocol redaction and database creation•Provide support to sites during the complete lifecycle of a trial•Managing CROs•Set-up, execute and follow-up on quotation request, bid review, develop guidelines for site, imaging management•Assist in the review of project contracts with the Contract Unit•Closely collaborate with the Regulatory Unit in meeting compliance with regulatory requirements during activation, conduct and closure of the trial•Reviews and validate expenses by sub-contractors related to the conduct of the study•Plan, organize, follow-up on meetings between internal team and external parties Involved in the following studies:EORTC 1410 - ABT 414 for recurrent GlioblastomaEORTC 26101 - Bevacizumab and lomustine in recurrent glioblastomaEORTC 1313 - SpectaBrainEORTC 1320 - Treabectedin in high grade minigiomaEORTC 26091 - Bevacizumab in Recurrent Grade II and III Glioma (TAVAREC)EORTC 26081 - The Codel trial

- Responsible for remote monitoring and site management of Phase II-IV clinical research studies, conducting all types of remote monitoring visits, inclusive of monthly site management calls.- Maintaining effective communication with sites, establishing solid relationships with Investigators and all other site staff. - Primary contact for all sites on assigned studies, manage assigned sites via inbound and outbound telephone calls. - Ensuring sites have the required study training and compliance with the protocol, regulatory guidelines and study procedures. - Monitors site performance metrics and patient enrolment. - Reviews eCRFs completed by sites and assists the site in resolving queries and/or other identified data collection issues. - Completes and submits visit reports according to SOP/Works Instructions (WI) or Sponsor requirements. - Documents and tracks the resolution of all outstanding site-specific protocol-related issues. - Prepares for and attends Investigator meetings, clinical monitoring staff meetings, project team meetings and clinical training sessions.

Main research project : Identification of new potentially accessible biomarkers of human glioblastoma.-Collection of human tumor samples-Extraction, purification and analysis of accessible proteins using mass spectrometry techniques-Investigations on accessible new potential cancer biomarkers -In vitro and in vivo validation of the new biomarkers identified-Developing of new animal model for in vivo biomarker validation

Breast Cancer research project- To perform immunohistochemistry experiments