Responsible for all clinical data management (CDM) activities in support of the clinical development therapeutic areas. Responsible for leading the CDM management team in developing and overseeing implementation of departmental strategy and ensuring its alignment with key partner's strategies.

- Ensure global standardization and consistency across all CDM sites and sub-functions with respect to processes, roles, training and development programs in order to develop a world-class and effective CDM function- Support the Global Head of CDM in setting strategic direction- Lead activities and knowledge sharing to improve and maintain the quality of processes and deliverables across the CDM functions globally- Provide oversight of process improvement working groups in CDM- Collaborate with other functions to ensure clear cross-functional interfaces to support best practice

- Development Information Access (Dev IA) designs and implements projects that make it easier for researchers and decision makers to access and use data and other information collected or acquired by the Development organizationDevelopment Information Access (Dev IA) designs and implementsprojects that make it easier for researchers and decision makers toaccess and use data and other information collected or acquired bythe Development organization- Responsible for defining Dev IA business policies and strategiesand ensuring successful implementation of approved Dev IAprojects

- Ultimately accountable for ensuring prompt, high quality, efficient delivery of clinical data management services in support of clinical development and post-marketing trials- Functional head of a 80+ person clinical data management department with three director and management-level direct reports- Span of responsibility includes data processing, data coordination, clinical programming, laboratory data management, data standards, medical coding, CRO management and EDC implementation- Accountable for planning and managing department budget- Led the planning and execution of a department reorganization to support efficiency, scalability and the transition to widespread EDC deployment

- Responsible for ensuring direct data management support for oncology, immunology, pulmonary and other therapeutic area trials. Direct reports are five management-level employees, with a more than 20 permanent and contract indirect reports- Participate as the data management representative on two therapeutic area management teams- Leader of electronic data capture (EDC) technology and process implementation- Data management representative on company-wide protocol review committeeIdentified CDM resource requirements for all direct project support

- Managed Oncology data management group (August 2001 – March 2002) and the data processing group (since February 2001). Five direct and 10 indirect reports- Participate as a member of the oncology therapeutic management team- Leader of a strategic initiative to plan for implementation of remote data capture (RDC) technology and processes in Medical Affairs- Previously responsible (November 1999 – October 2001) for managing the safety data management group, including coding and laboratory data administration- While managing the safety data management group, was responsible for planning MedDRA implementation for clinical and post-marketing event reporting, including implementation of new coding and thesaurus management system (Oracle TMS 4.0)- Previously managed (January 2000 – March 2001) data managers working on cardiovascular projects and participated as member of therapeutic area management team- Clinical sub-team leader in collaborative drug development project (March 2000 – May 2001). Coordinated team activities, facilitated communication and issue resolution with a partner company, developed project plan for go/no go decision making process and developed plans for controlled communication of phase III trial results

- Managed data managers working on cardiovascular and oncology projects (5 – 7 direct reports)- Identified and helped resolve issues related to implementation of new clinical data management system (Oracle Clinical™) and related processes- Reviewed data management plans, data quality plans and database definitions to ensure correct functionality and adherence to standards- Responsibilities included employee coaching and training, performance reviews, performance counseling, budgeting, resource planning, recruitment and participating as a member of a therapeutic area management team- Represented data management on a cross-functional CRO advisory team responsible for CRO pre-qualification, assisting teams with CRO selection and management, and defining guidelines for CRO use

- Data manager and implementation team member on phase I and phase II cardiovascular and oncology projects- Responsibilities included CRF design, data management plans, data quality plans, data entry screen design, edit check coding, database definition and data review- Lead selection of a data conversion tool to be used in converting data from Informix databases to Oracle Clinical. Developed process and training materials to facilitate use of selected conversion tool

Member of the Board responsible for setting strategic direction and goals for SCDM.

- Managed three permanent database developers plus contractor employees- Responsible for planning and managing clinical department information systems budget- Project manager for remote data entry (RDE) pilot project- Member of clinical department reengineering initiative core team

Designed and programmed databases and software in support of the Program on the Surgical Control of Hyperlipidemia (POSCH) study. Acted as system administrator for Coordinating Center minicomputer.