Anna Guaita Email & Phone Number

Mendrisio, Canton Ticino, Svizzera

Ticino, Svizzera

- Support the management of clinical projects in the different phases of study (Phase I-II-III-IV) up to product registration.- Independently manage activities related to clinical trials.- Perform Site selection of the clinical trial, Pre-study visit, Site Initiation Visit, unblinded Monitoring Visit and Close Out Visit, Co-Visits and Performance Assessment- Vendor selection (es CRO) involved in the management of clinical trials.- Prepare the necessary documentation and material so that the clinical trial can start and continue in accordance with GCP, internal SOPs and Italian/European regulations.- Collaborate in the drafting of protocols and Clinical Study Reports (CSR)- Contribute to the strategy of Site Recruitment, contingency planning and research of collaborations with other functional areas to achieve the goals of clinical trials.- Collaborate in the definition and updating of the budget and monitor the status of payments according to milestones for each clinical study.- Take care of the research, maintenance and possible updating of the bibliographical material.- Contribute to digital transformation and implementation of digitalization, collaborating with the involved departments.- Cooperate with Pharmacovigilance regarding the safety of products.- Interact with Pharma R&D staff to meet the needs of clinical trials.- Keep up to date on the developments of clinical research of interest to the company, both in self- training mode or participating in external events Collaborates with the Quality Assurance for ensuring compliance with GCP/ GMP standards also participating in the drafting of company SOP- Participate in and support GCP inspections by Competent Authorities- Manages the Medical Enquiries regarding the answer, archiving, reconciliation and updating of the medical enquiries tracking table, according to company procedures.

- Monitor study progress to assure compliance with protocol-requirements, regulation and Good Clinical Practice by conducting site visits as directed- Participate in study development. Perform site selection, initiation, monitoring and close-out visits for a variety of protocols, sites and therapeutic areas- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations- Conduct initial and ongoing site, sponsor, and project staff training as necessary. Establish regular lines of communication with sites to manage ongoing project expectations and issues.- Monitor and track patient enrollment and ensure the timely accurate and complete study data- Assist the Sponsor in problem solving and provide consultation on study related activities.

Milano, Italia

Involved in 25 international multicentre clinical protocols Phase 1, 2, 3 e 4 according to ICH-GCP principles. GCP training ad hoc clinical protocol.Clinical data entry, Case Report Forms (CRF) and / or electronic CRF (eCRF); Management and timely resolution of queries; Document Management (Ethics Committee); Drugs Management (registration and accounting, compliance with the requirements of conservation, control and re-supply, use of IWRS/IVRS system; Documents Archive; Monitoring of drugs (ADRs reports, collection and circularization of the SAE/ SUSAR); Management of shipments of biological samples to centralized laboratories; Management of monitoring visits (SIV,MIV,COV); Interaction with a team of the clinical study (Investigators, Nurses, Ethics Committee, Pharmacists, Sponsor); Collaboration with the Departments of the Hospital (Radiology, Laboratory Medicine, Pathology); budget analysis.

Epidemiology - Public Health

Milano

Sintesi chimica di idantoine e caratterizzazione NMR; test in vitro di molecole di sintesi.

Biotecnologie, Università Degli Studi Di Milano

Ich Gcp