Experience

ONYX PHARMACEUTICALS – SOUTH SAN FRANCISCO, CA

Clinical Data Management

7/2012 – present

Manager, Clinical Programming
• Implement SAS programming standards to increase efficiency and promote consistency.
• Develop system integrations to decrease manual data processes and leverage information across the organization.

•Establish lab standards to promote consistency across studies in support of combined filings and summaries.

•Evangelize new technology and techniques throughout Clinical ProgramMing and Data Management.

ABBOTT VASCULAR – SANTA CLARA, CA

Worldwide Data Management
3/2011  – 7/2012

Manager, Clinical Programming
• Initiated Rave Knowledge Sharing program to increase standards adoption, develop organizational expertise, and decrease trial build costs and timelines.
• Chair of the Global Standards Review Board to set data collection and reporting standards for Clinical Research.
•Guide and mentor approximately 10 staff in the design and development of EDC for clinical trials.

Clinical Solutions
2/2010  – 3/2011

Project Manager
•Established study design standards for study metric reporting that eliminated per study setup costs of approximately $100,000 annually.
•Designed and developed project and trial management dashboard to increase visibility of clinical operations and reduce redundancy for reporting.
•Lead cross-functional business teams (8-10) to reach consensus, efficiently utilize resources, and achieve objectives.

BAUSCH & LOMB- ROCHESTER, NY

Research & Development

3/07  – 2/10
Project Leader
•Successfully implemented a global quality management system that increased accessible data ten times, improved quality, and dramatically reduced the delay of information to other departments.
•Ongoing implementation of a Cognos data warehouse solution to provide increased visibility of complaint handling and product performance.
•Developed several SharePoint applications to support standardized global processes for data collection.

UNIVERSITY OF ROCHESTER – ROCHESTER, NY

Clinical Trials Coordination Center

1/02  – 2/07
Manager, Development & Systems
•Evaluation and implementation of Clinical Data Management System to increase operational capacity and decrease startup times for new studies by 50%.
•Performed vendor qualification and assessment, including onsite audits of vendor’s process control, policies, and procedures, to ensure necessary regulatory compliance and proper software development life-cycle practices.

Department of Emergency Medicine

11/99 – 11/01
Project Manager / Lead Analyst Programmer
•Led Visual Basic application development resulting in 300% increase in data elements and a decrease from 90 days to 7 days for data availability.

Department of Medicine

8/97 – 11/99
Information Analyst/Analyst Programmer
•On-time and on-budget migration from SunOS to Windows NT Domain including upgrades to eight servers and over 500 desktop systems including creation of new procedures and delivery of application training.

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