Florencia Corazza

Experienced Pharmacist working in the pharmaceutical industry with 18+ years in Clinical Research going through different roles, acquiring deep knowledge and hands-on experience in several areas of expertise (Clinical Data Management, Operations Management, Clinical Monitoring, QA/QC Audits, Regulatory submissions). 
Strong leadership and management skills, with a positive mindset, minimizing the stress, giving support and collaboration, generating commitment and motivation from all team members.
A passion to be part of an innovative company, focused on improving patients’ lives. 
TAs: Vaccines, HIV, Neurosciences, Cardiovascular, Rare Diseases, Oncology, Respiratory, Diabetes, Pediatric, Endocrine, Woman Health. Phases: II/III/IV

Senior Clinical Project Lead

ICON plc: Oct 2022 - Apr 2023

• Local Manager in charge of the entire study processes as regulatory, protocol compliance, site performance, measures and timelines for assigned trials, ensuring GCP/ICH, Study Protocol, FDA, ANMAT and SOPs adherence.
• Performs feasibility and budget negotiation to meet recruitment goals.
• Organizes study specific training and team meetings with CRAs and customers for all aspects of the projects.
• Participates in investigators and study meetings.
• Maintains regular contact with Medical Advisors, Medical Affairs, Global Monitoring team.

Senior Specialist Clinical Data Manager

MSD: Aug 2015 - Oct 2022 

• Selected as a member of the Global Root Cause Analysis Team.
• Managed multiple projects simultaneously, utilizing SQL and data analytics.
• Led multi-country & multicultural DM Teams actively participating in cross-functional decisions.
• Successfully achieved multiple Study Milestones (FSR, Safety & Efficacy 1nterim Analysis, Data Base Lock, Submissions) in compliance with GCP, FDA, SOPs, MedDra, SDTM.
• Main point of contact of the Data Management Team with internal stakeholders, clinical operations, medical monitoring, and vendors.
• eCRFs/EDCs design, Data Collection and Integrity maintaining high data quality throughout the study, External Data Flow and Reconciliation, Data Validation tools and post-production changes.
• Hands-on experience with different database models, as Trial Master Files (TMF), EDC platforms (InForm 4.6, InForm 6.1, RAVE), DMW, Veeva Vault, and IVRS/IWRS/IRT systems.
• Developed Data Management Plans (DMPs) and Risk Data Management Plans, proactively addressing potential risks.
• With a keen Inspection Readiness mindset, I've successfully navigated inspections and audits.
• Speaker and Relationship Builder, I've presented at international investigator meetings and built strong business relationships.

Clinical Project Manager

GSK: Jul 2011 - Aug 2015

• Achieved multiple project goals and timelines, coordinating the entire clinical trial process managing all involved parties as PIs, Site staff, Vendors, Study Medication supplies and CRAs resources, in compliance with GCP, Protocol, FDA, ANMAT and SOPs.
• Authored and maintained Risk Management Plan and Study Monitoring Plan.
• Successfully negotiated study budgets with PIs/KOLs and performed feasibility.
• Successful results in inspections and audits
• Managed the monitoring program and the objectives of the clinical project teams.
• Supervised & mentored CRAs.
• Conducted QA On-Site visits for audits & inspections.

 Senior Clinical Research Associate

GSK: Jul 2008 - Jul 2011

• Achieved multiple project milestones and timelines, managing the execution and performance of study deliverables.
• Ensured the delivery of high-quality and reliable data from monitored sites to support study goals.
• Actively participated in audit organizations and inspection readiness activities.
• Participated in audit organizations and inspection readiness activities.
• Represented the Sponsor at International Investigator Meetings.

 Clinical Research Associate

GSK: Aug 2006 - Jul 2008

• Led site staff across the country in monitoring multiple studies simultaneously, fostering an inspection readiness culture.
• Demonstrated an in-depth understanding of study protocols across multiple Therapeutic Areas and phases.
• Conducted On-Site/Off-Site monitoring visits in accordance with SMP (SDV/SDR), Protocol Compliance, query metrics, Data Quality (ALCOA), and GCP/ICH compliance.

 Quality Assurance Specialist

GSK: May 2004 - Aug 2006

• Maintained robust quality control of medication products, developing, testing, monitoring, and modifying processes for every defined cycle.
• Coordinated quality tests activities and reviewed, created technical specifications processes.
• Conducted routine internal audits and resolved issues affecting product quality such as GMP guidelines, SOPs, and Regulatory deviations.
• Participated in inspections and audits, investigating Root Cause Analysis till CAPA development.

 Analytical Development Analyst

Gador: Jan 2001 - May 2004

• Led the development, validation, implementation, verification, and transfer of analytical procedures in compliance with GMP, GLP, SOPs, ANMAT regulations.
• Developed Drug stability studies, demonstrating strong scientific and analytical thinking and knowledge.
• Strong scientific and analytical thinking and knowledge.

• University of Buenos Aires - Pharmaceutics - 1995 – 2001.
• Universidad Austral, Buenos Aires - Certified Clinical Research Associate - 2002 – 2003.
• Saint Gabriel's High School - Bachelor of Biological Sciences -1990 - 1994.