Vito Grande Email & Phone Number

• 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.
• 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.
• 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.

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.

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.

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.

- 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.

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