silvana valentini

Responsible for a total of 13 Partner sites located in Italy (Campania and Puglia region plus Milan and Rome areas). Accountable for building and managing site relationships while overseeing site-level feasibility, study start-up, conduct, and close-out activities across different therapeutic areas as liaison between CRO and investigational sites building investigator and site staff awareness on clinical trials. To develop the knowledge of site capabilities & to build company network and to promote clinical trials. Manage proactive issue monitoring and management. Develop and maintain long-term relationships with: PIs, General Manager &/or Scientific Head. As well manage communication internally and externally (Sponsor, Feas/SID team, Sites, Reg Start up, CPMs, CRAs etc..)

* Responsible as Line Management: Candidate interviews * CRA and CTA Allocation according with client expectation * Supervision of their activities * Accompany visits with CRA * Regular meetings with client * Analysed data for CRA performance (recruitment, monitoring visits/sites, issues, audit finding, timelines). As Project Management responsible for Monthly project activities revision and billing activities.

Responsible for monitoring activities since SIV to COV, Partecipation to Investigator Meetings

Responsible, as Line Manager, for 12 CRAs (administrative aspects, allocation, training, performance and quality, professional development) Responsible for 5 Partner Sites and 10 tactital sites: develop and/or mantain collaboration & stategic relationship with Medical Doctors (PI, stakeholders, etc.) as well Administrative people (General Manager, Ethic Committee, Scientific Head etc.) and/or KoL. Sponsor Project Owner at the Country level for 2 programs for two different Sponsors: responsible for the projects perfomance at the country level, regular meetings with the client (F2F or webex), regular meetings with Internation teams, managing CRAs perfomance versus client expetactions, partecipation to IM, regular meeting with KoL or tactical PIs, preparation and discussion on study performance data at global and country level.

* Line Management & Project Management with the following responsibilities: * resource management * managing clinical trials (Oncolgy, Hematolgy, Neurology and CDV, Nephrology disease on phase I-phase IV) * coordination activities from SIV to COV * monitoring the proper conduct, documentation and progress of the study * reporting the study progress to the Client * maintaining financial control of the project budget * accountability for revenue maximization and profitability

* Developing Partner Sites relationship and building new collaboration with Investigational sites. * Responsible for managing 5 PS and about 22 tactical sites. * Develop and mantain collaboration with Medical Doctors (PI, stakeholders, etc.) as well Administrative people (General Manager, Ethic Committee, Scientific Head etc.) * As well, responsible also for the mentoring/coaching for 8 CRAs.