MANAGEMENT TEAM

SUSAN BORNSTEIN, MPH

Over 19 years of clinical research experience at Biotech, CRO, and academia including:

• Worldwide Director Data Management for a CRO and a Biotechnology company
• Project Leader for a global EDC implementation at a biotechnology company
• Member of Clinical Trial Optimization task force at a biotechnology company
• Development of fax and web based clinical data systems at CRO
• Evaluation of clinical data warehouse, EDC/CDMS, e-diary and CTMS vendors
• Member of outsourcing strategy team
• Clinical Data Management, Database development, SAS programming and standards development
• Director Product Development
• Previous SCDM Board of Director
• Current Electronic Clinical Forum Committee Chair

DEWAYNE CUSICK

Operations and project management specialist with more than 30 years of experience across multiple industries and technology platforms

• Manages leadership and delivery team for EDC Solutions services
• Primary contact for Medidata vendor relationship and authority on RAVE EDC solution
• Expertise in ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Technical project management expertise and leadership experience including scope management, work planning and work delegation
• Former VP Global Implementation Strategy & Management, Medidata Solutions
• Strategic and tactical oversight of Global Implementation Services for staffing
• Global PMO expertise in delivering projects, programs and customers

KRISTAN GALLITANO, M.Ed.

17 years of experience in Biotech and CRO including:

• Technical and Management positions
• Performing Data Management tasks for Phase I – IV trials and patient registries
• Developing, training and implementing SOPs for paper-, fax- and web- based systems
• Leader of Clinical Development Efficiency Team responsible for reviewing clinical trial process from Trial Planning through Trial Reporting, identifying redundancies and implementing change
• Creation and delivery of clinical development training modules
• Selection and Oversight of Data Management and Safety vendors

JOSEPHINE SCROFANI

• Management of national CRM (Customer Relationship Management) training implementation focusing on approximately 5000 users
• Assessment of training needs and training functions
• Knowledge of EDC systems and processes
• Development of user requirements for system or process implementations
• Development of training materials to support training initiative including user guides, reference cards, participant guides, workbooks and job aids
• Design and development of various training solutions (instructor-led training, web conferencing, asynchronous eLearning tutorials) applying Adult Learning concepts and the ADDIE Instructional Design Model
• Facilitation of technical, soft skills and process workshops customized to meet client need(s) and objective(s)

ANTONY GONCALVES

11 years of experience in Biotech and CRO including:

• Technical and management positions
• EDC Implementation Leader for a biotechnology company responsible for formalizing and standardizing EDC process for global implementation
• Developed and delivered EDC training to end users
• Functional Service Provider (FSP) Manager for a SAS FSP for a pharmaceutical company

RAJ INDUPURI

13 years of IT experience with over 8 years in the Biotechnology industry including:

• Led projects to implement and integrate different components of CDMS/EDC systems
• Evaluated, implemented and maintained EDC and related eCDM technologies
• Developed global library of data standards and edit checks
• Implemented operational metrics program

CHERYL MCCARTHY, CQA, CBA

Over 15 years experience in CRO and Biotech industry including:

• ASQ Certified Quality Auditor and Certified Biomedical Auditor
• Vendor Assessment Audits
• Developed and implemented Internal Audit program
• Computerized System Validation for CTMS, Safety Tracking, Clinical Data Management and Coding systems
• Developed and implemented a Quality Management System for a CRO
• Quality Manual, SOP, Work Instruction, User Manual, Training Guide Development
• Developed and maintained corporate Training Program
• Provided training on 21 CFR Part 11 and GCPs
• Disaster Recovery/Business Continuity management, testing and training
• Member of DIA SIACs for GCP/QA and Validation

KATRINA RICE

Over 10 years experience in EDC solutions including strategic planning, operational deployment, training, and infrastructure:

• Managed operational support team for Medidata's Rave from study build through lifecycle of trial
• Primary contact for service providers (e.g. EDC providers, IT organization, Service Desk) and Global Clinical Operations
• Expertise in ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Technical project management oversight in support of EDC
• Coordinate development of processes and technical solutions for web based training, data transfers and database integrations with other clinical systems
• Former Manager R&D Organizational and Information EDC Support, Bayer Healthcare Pharmaceuticals

SHERRI DEGIORGIO

28 years experience in the Pharmaceutical and Biotechnology industry including:

• Led Data Management Process Improvement Initiatives for the continuous improvement and implementation of standard procedures
• Created and Delivered Data Management Process Training
• Managed the Data Management process from Trial Planning through Trial Reporting for multiple Phase II-IV clinical trials
• Developed global data standard library
• Developed Standard Operating Procedures, Work Instructions and Process Maps
• Monitoring and Site Management
• Management positions directing both projects and people

PARAG SHIRALKAR, MS; MBA

9 years experience of IT and Bio-Pharma experience including:

• Certified CDISC, SAS, and Six Sigma management
• FSP Lead for clinical programming
• Extensive experience in Base SAS, SAS Macros, SAS/IML, SAS/Access, SAS/Connect, SAS/SQL, SAS/ Graph, and SAS/Stat. Experience in developing SAS procedures, macros, and applications for data cleaning, reporting, and documentation
• Managed projects involving clinical reporting of phase-I to phase-IV clinical trials, E-submission, and integrated summaries of clinical safety.
• Experience in Training management and compliance

MARY BELGARD, MMHS

28 years experience in the CRO, Pharmaceutical and Biotechnology industry including:

• Managed the Data Management process from Trial Planning through Trial Reporting for multiple Phase II-IV clinical trials
• Vendor/CRO selection
• CRO oversight including quality control checks and metrics tracking
• Created data management training modules
• Conducted training for Clinical Investigators, Site Coordinators, and CRAs
• Led team charged with global implementation/integration of CDMS
• SOP and guideline development
• Medical coding (MedDRA, WHO-ART, ICD-9, WHO Drug) and safety reporting
• Developed and delivered training on safety processes/policies