Coordination of clinical trials conducted in the Country/BA/RE to ensure that targets are met in a timely manner and control and follow up of trial activities to ensure overall quality of the project.• Review/collect documents for CTA package• Validation/local adaptation CTA from EUDRACT for ECs and HA• Ensure submission Clinical Trials Protocol and Amendments to HA and EC according to project timelines• Contract preparation, negotiation and finalisation• Site selection• Trial Site Initiation• DBL and Cleaning Cycle achievement according to the specific timelines as KPIs• Ensure Trial Closure activities• Achievement of Recruitment & Retention goals according to agreed timelines defined by projects (Preparing recruitment strategy at country and site level in agreement with Clinical Trial timelines)• Trial Product management according to GCPs, all related NN SOPs and external requirements• Overview on managing trial materials (eg: Bg meters, strips, lancets, patients questionnaires etc.)• Clinical Trial Budgeting and monitoring of expenses responsibility • Trial related meetings attendance (such as: Investigator meetings, ISG, etc..)• Quality Activity Plan (QAP) activities monitoring• Audit&Inspections activities according to Legislation and NN SOPs requirements• LTM and RTM role • Review of monitoring visit reports

Trial activities• Accountable for the country budget according to ClinCost procedures• Provide consolidated country input for review of key documents (e.g. protocol and related documents)• Consolidate systems and vendor input per country as applicable (e.g. CRF and diary)• Ensure timely applications, response to questions and approvals for EC/HA and IRB/IEC • Ensure update of IMPACT at trial country level• Ensure approval of local IMP label and coordinate handling of trial products as applicable• Prepare the country recruitment and mitigation plan incl. consolidating the CRA site plans• Monitor recruitment and retention of trial subjects and take appropriate actions according to the agreed country plan • Provide trial status update and other reports or feedback as required to the RTM or ITM (if applicable)• Ensure data cleaning milestones and DBL deliverables according to the Data Flow Plan• Ensure review, approval and follow-up of monitoring visit reports incl. protocol deviations• Ensure filing and archiving of trial related documents in the Trial Master File at the country level• Ensure compliance with GCP, ICH and local regulations• Initiate and drive contracts with sites as per local practise• Support the CRAs within activities for trial site selection, site initiation, monitoring, recruitment and site closure

Training ScientificooStudio della letteratura scientifica e aggiornamento costante della forza vendite (ISF, Area Manager, MSL)oConoscenza di specialità medicinali Cephalon nel campo oncologico, ematologico, nefrologico, omeostatico e neurologico ed analisi comparativa dei competitoroConoscenza del sistema aziendale di gestione delle gare d’appalto FarmacovigilanzaoGestione dell’archivio cartaceo ed elettronico di Training Scientifico e di Farmacovigilanza oInvio e ricezione di ADRs e CIOMS tra Cephalon e AIFA entro la tempistica oConoscenza del sistema RNF (Rete Nazionale di Farmacovigilanza) e database di Gruppo per la gestione della documentazione di Farmacovigilanza oInvio di PSUR e DSURoApprofondimento della normativa internazionale e nazionale in materia di FarmacovigilanzaStudi ClinicioSupporto alla Direzione Medica e alle attività di Ricerca ClinicaoRelazioni con Comitati Etici, Investigator, Data Manager e CROs oGestione del farmacooGestione dell’archivio cartaceo ed elettronico

Tecniche di biologia cellulare:oColture cellulari oIsolamento di PBMCs da sangue perifericooImmortalizzazione di linfoblasti umanioEsperimenti di stimolazione su colture cellulariTecniche di biologia molecolare:oTecniche di estrazione di acidi nucleici da sangue intero e da PBMCsoTecniche elettroforeticheoDosaggi ELISAoTecniche di analisi citofluorimetricaoReverse Transcriptase-Polymerase Chain Reaction (RT-PCR)oReal-Time PCRoTecniche di isolamento di PBMCs da sangue interooUtilizzo del lateral-flow immunoassay (dipstick)oQuantizzazione di acidi nucleici e proteine