Federica Dellera

• Partner with global and local country teams to provide high level country strategy and actively drive study progress and local/country level study delivery.
• Accountable for study results and drives key decisions within country.
• Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study Team (LST).
• Contribute and develop program/study-specific materials – e.g., monitoring plan, study specific training documents.
• Accountable for site-level goal setting and study-specific deliverables for clinical sites within the country.
• Manage, oversee and supervise applicable vendor activities e.g., laboratories and equipment provisioning.
• Provides country level input into the Country Operational Plan (COP) and partner with the Development Feasibility Manager through feasibility and with the Global Clinical Managers (GCMs) to ensure local delivery of the study.
• Provide updates regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range).
• Conduct on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships.
• Implement regulatory agency inspection readiness activities (e.g., TMF review, story board generation).
• Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g., vendor management.
• Coordinate site contracting, budgeting, insurance and payment process by supervising local support roles.

- Ensure an execution on-time of the assigned clinical studies, in line with the approved budget, achieving the qualitative/quantitative objectives agreed with the Sponsor;

- Refer as contact person for Investigators, Monitors, Sponsors and third parties involved in the assigned clinical trials;

- Acquire documentation produced by Sponsors and other parties in order to support the submission of a clinical trial;

- Collaborate in the creation of study documents drafts such as Protocol, Informed Consent and Case Report Form (CRF);

- Ensure the activation and the conduct of studies at the involved clinical sites, supervising the monitors;

- Provide study specific training (Protocol, CRF etc.) to the monitors and, where required, to the site staff involved;

- Manage observations made during an audit/inspection of a clinical trial and ensure that the necessary corrective actions are implemented;

- Implement and maintain the necessary procedures for the clinical trials management in accordance with GCP;

- Refer as Line Manager for Monitors.

- Conduct clinical study (phase I, III and observational studies) in compliance with the currently approved study protocol/amendment(s), with ICH GCP, SOPs and any applicable regulatory requirements;

- Conduct on-site monitoring visits (pre-study, initiation, routine monitoring, site closure);

- Ensure timely collection/upload of essential documents into the eTMF in accordance with ICH-GCP, SOPs and local requirements;

- Create and maintain contacts with investigator sites and KOLs;

- Drive performance at the sites, identify and escalate potential risks and identify retraining opportunities for site study teams;

- Mentor junior CRAs.

- Support the team in the preparation, handling, distribution, filing and archiving of clinical documentation and reports;

- Assist with periodic review of study files for accuracy and completeness;

- Experience in co-monitoring visits (selection, initiation, routine, closure visits).

- Manage research projects in the cardiovascular and nutraceutical area;

- Present scientific data at national and international meetings;

- Publish papers on scientific peer-reviewed journals;

- Manage human resources (trainees, students).

Professional experience related to the project “Dote Comune”

(funded by Regione Lombardia and Ancitel Lombardia)

Management of the librarian heritage and organization of cultural events.

Study of the role of magnesium in the proliferation

of osteoblast-like cells and in the pathogenesis of osteoporosis.