Silvia Paganini

• 3+ years of experience managing and coordinating clinical studies from study start-up through close-out in compliance with ICH-GCP and ISO 14155 requirements.
• Led end-to-end clinical trial activities, including protocol development, regulatory and ethics submissions, site initiation, monitoring oversight, study close-out, and Clinical Investigation Report (CIR) preparation.
• Managed study timelines, milestones, and deliverables while ensuring quality, compliance, and operational efficiency throughout the study lifecycle.
• Oversaw patient recruitment and enrollment activities, tracking study performance and implementing actions to support enrollment targets.
• Conducted ongoing review of clinical data, query management, and data quality oversight to ensure data integrity and protocol compliance. Monitored investigational sites, ensuring adherence to study protocols, GCP requirements, and sponsor expectations.
• Designed and developed electronic Case Report Forms (eCRFs) and supported database requirements in collaboration with cross-functional teams.
• Collaborated with investigators and internal stakeholders to facilitate successful study execution and timely delivery of project objectives.
• Experienced in Post-Market Clinical Follow-Up (PMCF) studies and generation of clinical evidence in accordance with ISO 14155 requirements.
• Maintained essential study documentation, supported audit and inspection readiness activities, and ensured compliance with quality management systems.

• Conducted qualification, initiation and monitoring visits
to assess site performance and achieve agreed protocol
standards.

• Updated Investigator Site Files with current, accurate
information, demonstrating compliance with Good
Clinical Practice (GCP) requirements.

• Assessed site supplies, drug stocks and drug
accountability to maintain safe, productive study
environments.

• Reported Serious Adverse Events quickly with
meticulous detail, enabling rigorous follow-up analysis
to prevent repeat issues.

• Managed source data review and verification processes
to achieve alignment with monitoring plans.

• Communicated regularly with sites and vendors to
monitor study progress and achieve project
expectations.

• Collaborated with site teams to adjust, drive and track
recruitment to achieve enrolment targets.

Coordinated safe and successful laboratory
experiments designed to test theories related to COVID-
19 samples.