Vito Grande Email & Phone Number

Sesto San Giovanni, It

• Works with the Clinical Operations (CO) Manager to develop goals and strategies aimed to conduct clinical trials or clinical investigations adequately, respecting budget and milestones agreed with the sponsor, and ensuring compliance to protocol or clinical investigation plan and procedures.• If requested by the sponsor, provides support in feasibility assessment and sites selection.• Reviews the clinical protocols or clinical investigation plans to evaluate and identify critical factors such as investigational product handling, potential risks to subjects, biological samples collection and handling, data collection and management.• Assists the Regulatory Officer in setting up and maintain TMFs.• Assist the project team in the preparation and distribution of project-related correspondence (e.g. agendas, meeting minutes, tracking spreadsheets, newsletters and presentations).• Assists the Event Specialist with planning, organization and conduct of meetings with customer, investigators and partners.• Supports sponsors and investigators in the resolution of issues and problems.• Supervises monitoring activities, performed either by employed or free-lance CRAs, to ensure compliance with study protocol or clinical investigation plan and procedures, as well as local and international regulations.• Reviews the Monitoring Visit Reports, suggests appropriate follow-up actions as needed, and escalate critical issues, if any, to the CO Manager and Sponsor.• Provides continuous training to site staff in scientific and operational aspects of clinical trials or clinical investigations, focusing on the most critical ones.• If committed by the sponsor, interacts with laboratories and sites in order to ensure adequate handling of biological samples (i.e. collection, labeling, storage, shipment, processing).• Checks the regular supply of investigational products (drugs, medical devices or other categories of product) to sites.

Monza E Brianza, Italia

- Coordinate CRO and Universities responsible to conduct clinical trials. - Oversight of clinical research conducted at investigational sites to ensure compliance with study protocols, applicable regulatory standards, IRB/EC policies and procedures and business policies. - Define synopsis and protocol in coordination with the responsible of the study - Monitor progresses, results and publications of the above-mentioned trials.- Review of the Monitoring Reports (PSV, SIV, IMV & COV)- Review of ICF (Informed Consent Form), CTA (Clinical Trial Agreement) & Study Plans (Monitoring Plan, Project Management Plan..) - Management of the Vendors- Review & Management of the Budget for the assigned projects.

Milano, Italia

Milano, Italia

• Remote Review of EDC (with or without source verification, depending on local practice and regulations). Where possible, and in compliance with local laws, performs source data verification from web-based sources• Writes, follows and resolves clinical queries and issues• Remote review of drug accountability log• Conducts site management calls according to the monitoring plan• Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes in order to assess site’s ability to conduct study• Providers refresh trainings, follow up on outstanding administrative needs (e.g., outstanding/updated regulatory documents), assists with regulatory reviews, as requested, updates CTMS with site contacts changes and maintains vendor tracker.• Review and escalates appropriately key risk/performance/ quality indicators (KRI, KPI, KQI [e.g., early termination and screen fail rates, average number of open finding , etc.]), ad hoc clinical listing review, tracking and trending of violations and deviations, ensuring visits occurred per Monitoring Plan, site status, enrollment, CRF status and SAE follow up.• Liaises with CRA to prompt collection of documents, review of data points, finding from EDC and file review.• Provides trial status tracking and progress update reports to CTM (Clinical Trial Manager) as required.• Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System – CTMS)• Conducts remote investigations into site performance issues at the directive of the CTM.• Assists in ensuring audit ready files. Contributes to company, client, and federal/local regulatory requirements/audit responses as needed.

Milano, Italia

• Schedules and reviews trial tasks, provides leadership in the delivery of services to clients, ensures that staff fulfill their responsibilities in accordance with policies, procedures, and SOPs.• Serves as a Preceptor for new CRAs • Functions independently with minimal oversight required • May serve as subject matter expert for CTM on monitoring related activities • Monitoring of studies Oncology (Multiple Myeloma; Lymphocytic Lymphoma or Follicular, Breast Cancer)

Milano, Italia

Monitoring of studies diabetesMonitoring of epileptic studiesMonitoring of psoriasis studies Partecipation Investigator & Monitor MeetingMonitor and maintain ICH-GCP compliancePerform site facilities inspectionConduct on-site study-specific training Perform on site visits in accordance with the monitoring planResponsible for the completeness and quality of the on-site filesEstablish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit

- Preparation of document for submission EC (Ethical Committee) and AC Competent Authority- Monitoring authorization procedures- Monitoring Visit, recruitment, implementation of protocol, handling drug and site closing - Coordination of CRO (Contract Research Organization)- Quality Control for CROs and Auditing activities- Updates of AstraZeneca program informatics - Monitoring of studies Oncology- Monitoring of studies Respiratory- Monitoring of studies Cardiovascular- Partecipation Monitors Meeting- Partecipation Investigator Meeting

CTA (Clinical Trial Assistant), supporting Pharmacovigilance Unit and Documentation Unit

Master In Management E Marketing Dell'Industria Farmaceutica, Pharmaceutical Marketing And Management

BETA-THALASSEMIA: LANCIO DI UN NUOVO PRODOTTO PER UNA MALATTIA RARA

Executive Mba, School Of Management

Business Plan vSDV - virtual Source Data Verification

Master “Ricerca E Sviluppo Preclinico E Clinico Dei Farmaci”, Pharmaceutical Medicine

Degree In Science Of Biology, Functional And Molecular Biology

Bachelor Degree In Science Of Biology, Molecular Biology