Laura Fazio Email & Phone Number

New Port Richey, Fl, Us

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.

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.

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.

• 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.

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.

Raleigh, North Carolina, Us

Master Of Science - Ms, Clinical Research Administration

Bs, Management