Laura Fazio

Laura Fazio Email and Phone Number

Founder @ New Port Richey, FL, US
New Port Richey, FL, US
Laura Fazio's Location
New Port Richey, Florida, United States, United States
Laura Fazio's Contact Details

Laura Fazio personal email

n/a
About Laura Fazio

I possess a deep expertise in clinical research, highlighted by my extensive experience in Clinical Data Management (CDM) across various roles within the industry. My educational background in Clinical Research Administration provides me with a solid foundation in research methodologies, regulatory requirements, and ethical considerations essential for conducting successful clinical trials. In my recent leadership positions, I have managed CDM activities to ensure the highest quality of data and compliance with regulatory standards, developing clinical data standards and standard operating procedures (SOPs) that maintain the integrity of trial data. I excel at building and leading high-performing teams, ensuring all members are aligned with project goals and effectively contributing to deliverables.Moreover, my collaboration with cross-functional teams—including Clinical Data Analytics, Product, and Engineering—has allowed me to define system requirements and develop workflows that seamlessly integrate data management processes with technological solutions. Through my commitment to continuous improvement and strategic planning, I consistently deliver high-quality clinical trial data, ultimately contributing to successful study outcomes and advancing the goals of the organizations I serve. My passion for clinical research drives me to stay updated on industry trends and innovations, further enhancing my ability to lead teams effectively.

Laura Fazio's Current Company Details
Fazio CDM Consulting

Fazio Cdm Consulting

Founder
New Port Richey, FL, US
Laura Fazio Work Experience Details
  • Fazio Cdm Consulting
    Founder
    Fazio Cdm Consulting
    New Port Richey, Fl, Us
  • Open To Work
    Open To Work
    Open To Work Oct 2024 - Present
  • Formation Bio
    Director Clinical Data Management
    Formation Bio Aug 2023 - Oct 2024
    New York, Ny, Us
    • Lead Clinical Data Management (CDM) activities for all studies, ensuring the quality and compliance of deliverables while demonstrating subject matter expertise to drive team strategy and capabilities. • Build and manage a high-performing CDM team, including full-time employees, contractors, and third-party vendors, while maintaining primary accountability for resource allocation based on project milestones. • Collaborate with cross-functional teams, including Clinical Data Analytics & Programming and Product and Engineering, to define system requirements and develop integrated CDM workflows that enhance data management processes. • Oversee the development and implementation of clinical data standards, standard operating procedures (SOPs), and guidance documents, ensuring all CDM activities adhere to regulatory requirements and Good Clinical Practice (GCP) standards.
  • Veristat
    Director Data Management
    Veristat Nov 2021 - May 2023
    Southborough, Massachusetts, Us
    • Developed and executed quarterly and annual business plans aligned with unit goals and objectives, effectively communicating and translating company objectives to ensure employee engagement. • Optimized departmental processes and implemented project-specific strategies to enhance productivity and quality while reducing cycle times and costs. • Oversaw project-related data management tasks, including protocol design, creation, and finalization of case report forms (CRFs), and database design, ensuring consistency and adherence to project needs. • Managed Clinical Data Management and Database Development operations, including personnel hiring, performance evaluations, and resource allocation, while supporting effective communication with clients, Project Managers, and team members to ensure effective project delivery.
  • Mirati Therapeutics
    Sr Manager Clinical Data Management
    Mirati Therapeutics Mar 2021 - Nov 2021
    San Diego, California, Us
    • Oversaw and managed clinical data management activities from study start-up to database lock, ensuring compliance and quality throughout the process. • Coordinated with CRO vendors and cross-functional team members for protocol reviews, eCRF development, and database design specifications to ensure alignment with project goals. • Led data review processes and facilitated the timely delivery of complete, high-quality clinical trial data deliverables. • Ensured the integrity of clinical trial data through effective communication and collaboration among team members and external partners.
  • Depuy Orthopaedics
    Manager, Cdm
    Depuy Orthopaedics Oct 2012 - Mar 2021
    • Led all phases of team projects to deliver high-quality clinical data from over 70 resources across franchises, ensuring adherence to established timelines and budgets. • Fostered collaborations with BSDM partners and Clinical Operations leadership to develop comprehensive clinical trial project management plans, budgets, milestones, and delivery timelines. • Participated in vendor selection, contracting, and evaluation to ensure compliance with contract expectations and project requirements. • Oversaw project operations to maintain quality standards and optimize resource allocation throughout the clinical trial process.
  • Depuy Orthopaedics
    Team Leader, Cdm
    Depuy Orthopaedics Aug 2007 - Oct 2012
  • Inc Research
    Manger, Data Operations / Clinical Data Manager
    Inc Research Mar 2004 - Aug 2007
    Raleigh, North Carolina, Us
    • Led a high-performing and diverse data operations team, overseeing utilization, resource allocation, training, and daily operations to maximize efficiency. • Held full accountability for project quality, budget management, and adherence to timelines, ensuring successful project execution. • Directed the development and maintenance of project budgets and plans, facilitating effective resource allocation. • Collected, processed, and analyzed data while routinely evaluating data collection processes to ensure accuracy and validity of results.
  • Inc Research
    Clinical Data Associate I, Ii And Senior
    Inc Research Nov 2000 - Aug 2004
    Raleigh, North Carolina, Us

Laura Fazio Skills

Clinical Data Management Clinical Trials Data Management Sop Validation Process Improvement Clinical Research Crf Design Software Documentation Quality Assurance Data Analysis Edc 21 Cfr Part 11 Medical Devices Fda Cro Ctms Gcp Pharmaceutical Industry Regulatory Submissions Clinical Development Management Biotechnology Oncology Therapeutic Areas Regulatory Affairs Ich Gcp Leadership Life Sciences Cross Functional Team Leadership

Laura Fazio Education Details

  • The George Washington University School Of Medicine And Health Sciences
    The George Washington University School Of Medicine And Health Sciences
    Clinical Research Administration
  • Indiana Wesleyan University
    Indiana Wesleyan University
    Management

Frequently Asked Questions about Laura Fazio

What company does Laura Fazio work for?

Laura Fazio works for Fazio Cdm Consulting

What is Laura Fazio's role at the current company?

Laura Fazio's current role is Founder.

What is Laura Fazio's email address?

Laura Fazio's email address is la****@****tat.com

What schools did Laura Fazio attend?

Laura Fazio attended The George Washington University School Of Medicine And Health Sciences, Indiana Wesleyan University.

What skills is Laura Fazio known for?

Laura Fazio has skills like Clinical Data Management, Clinical Trials, Data Management, Sop, Validation, Process Improvement, Clinical Research, Crf Design, Software Documentation, Quality Assurance, Data Analysis, Edc.

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