OBJECTIVE
Seeking a challenging and professional SAS and/or database programming position
which leverages the breadth of my professional experience within the
pharmaceutical/biotechnology industry with a company providing growth and
development opportunities.
EXPERIENCE
Statistics & Data Corporation (SDC), Raleigh, NC 2008 - 2009
Director, Clinical Data Management
• Led and directed all aspects of Clinical Data Management in two operating
locations (Tempe, AZ and Raleigh, NC).
• Worked collaboratively with all other functional areas (project management,
clinical operations, SAS programming and Statistics).
• Led cross functional teams in structuring business practices towards the use
of Oracle Clinical and Oracle RDC
• Led cross function teams in database implementation of CDISC standards
• Developed and implemented new processes and procedures, streamlining data
management operations, improving department efficiency and reducing required
timelines without compromising quality.
• Worked closely with IT and QA on the implementation of clinical data
management systems while ensuring regulatory requirements are met.
• Implemented the data management system for specific projects, trained and
updated data management team as necessary.
• Coordinated and participated in departmental/corporate task forces and
committees as needed.
• Staffed the data management organization to achieve company objectives,
project demands, timelines and budget.
• Performed client and in-house presentations and participated in project status
reviews.
• Provided direct data management support as needed to support personnel,
projects and deliverables (CRF design, CRF annotation, medical coding, data
validation specifications, report programming and database design)
• Communicated with all departments regarding project status/issues.
• Conducted departmental evaluations and employee performance appraisals.
• Recommended appropriate compensation based on employee performance and
industry trend.
• Maintained knowledge of industry trends and data management standards by
attending industry conferences and meetings as required.
• Supported business development efforts, as required.
BattelleCRO, Newton, MA 2004 - 2008
Director, Clinical Data Management
• Responsible for overall management and organization of the Data Management
Department and worked collaboratively with other functional areas (project
management, biostatistics, clinical operations, medical writing and finance)
• Managed the implementation and validation of Oracle Clinical, RDC and TMS.
Coordinated and lead cross departmental teams in developing work processes and
system configuration to meet business practices.
• Organized all training efforts towards database design and application use of
Oracle Clinical and Oracle RDC
• Conducted continuous training for CDMs and CRAs in OC, TMS, OC/RDC
• Developed clinical database system and procedures for project specific needs
(development of questions, question groups, DVGs, DCMs, DCIs, data entry pages
(character and graphic layout) and procedures)
• Creation and maintenance of OC global library, TMS domains and DVGs and system
user accounts
• Developed and implemented new processes and procedures improving the
efficiency of the clinical data managers as well as streamlining data management
operations
• Oversaw development and implementation of the data management process through
application development and improved departmental operating procedures and cross
departmental work instructions
• Oversaw the activities of the data management staff including the development
of validated data management systems with SOP’s, workflows and electronic
clinical data system
• Worked closely with IT and Quality Assurance on the implementation of clinical
data management systems and ensuring regulatory requirements are met
• Implemented data management systems for specific projects, trained and updated
data management team as necessary.
• Coordinated and participated in departmental/corporate task forces and
committees as needed.
• Performed client and in-house presentations as needed
• Assisted in the development of Biometric workflows and oversaw Biometric
Central File system.
• Provided support and performed data management tasks as needed to support
personnel, projects and deliverables (CRF design, CRF annotation, database
development, edit check programming, medical coding, data validation
specifications, report programming)
• Identified, documented and followed up on data management out of scope
issues.
• Communicated with all departments regarding project status/issues, provide
ongoing feedback on DM workflows and technologies to increase efficiency and
provide feedback to Data Management Department, Clinical Research Department,
Regulatory Affairs and Corporate as necessary.
• Forecasted and maintained appropriate level of resources in accordance with
project demands and corporate objectives.
• Conducted departmental evaluations and employee performance appraisals;
recommended appropriate compensation based in employee performance and industry
trend.
• Maintained knowledge of industry trends and data management standards by
attending industry conferences and meetings as required
Abt Associates, Abt Applied Clinical Trials, Cambridge, MA 2001-2004
Associate Director, Clinical Data Management, Biostatistics and Epidemiology
• Responsible for the organization and management of all aspects of clinical
trial data for Phase II, II and IV trials. Specific indications include
cardiovascular, ophthalmology, neurology.
• Developed and implemented new processes and procedures for streamlining data
management operations and improve efficiency of the clinical data managers.
• Interacted extensively with clients and other departments to develop client
specific processes.
• Oversaw development and implementation of the data management process through
application development and improved operating procedures.
• Provided support and performed data management tasks as needed to support
personnel, projects and deliverables (CRF design, CRF annotation, database
development, medical coding, data validation specifications, report programming)
• Primary contact for internal and external clients, team members, and staff for
resolving any data management related issues or problems.
• Represented department in initial project interaction with client and client
audits.
• Estimated data management resources required for all projects.
• Assigned data management tasks and prepare work schedules.
• Developed and Monitored budgets and schedules.
• Trained and supervised all clinical data managers and data entry personnel.
• Maintained the appropriate level of staffing in accordance with project
demands.
• Conducted departmental evaluation and employee performance appraisals and
recommended appropriate compensation based in employee performance and industry
trend.
Diatide, Incorporated, Bedford, NH 1997 - 2001
Manager, Data Management
• Developed data management department and established data management systems
and processes for in-house management of Phase I, II and III clinical trial data.
Indications include thrombosis, medical imaging and lung cancer.
• Managed all aspects of data management activities across all clinical
projects
• Coordinated and oversaw activities for all in house personnel, consultants and
contract research organizations.
• Generated and managed project timelines for all clinical trial data management
activities
• Generated and maintained data management fiscal year budget for all projected
projects
• Ensured database integrity for all clinical trial projects
• Developed ACCESS database systems
• Programmed data validation specifications to ensure adherence to protocol
using SAS
• Generated reports/data listings utilizing SAS
PAREXEL International, Waltham, MA. 1996 - 1997
International Project Manager - International Project Management
North American Research Operations
• Overall project management of multi-site Phase II, III and IV clinical trials.
Indications included allergies, respiratory and neurology.
• Key operational interface between client, investigators, project team and
third party vendors
• Managed/coordinated all project activities (project initiation, resource
planning and management, scheduled project activities and deliverables,
tracked/reported study progress and prepared financial forecast)
• Communicated effectively with all levels of personnel re: scope of work,
timeline, project goals, technical information and client input to ensure timely
completion of project.
• Responsible for ensuring the quality of work performed and adherence to
protocol
• Oversaw daily activities of project team: clinical monitors, clinical data
managers, database manager, statistical programmer, biostatisticians, medical
writer and medical director.
• Monitored project tasks and progress against the contract/project plan,
identified any deviations and provided resolution.
• Identified requirements for contract/budget amendments based on scope of
changes and initiated necessary action.
Clinical Data Manager - Biostatistics and Data Management Services 1993 - 1996
• Managed and coordinated with client, project manager, statistician, medical
monitor, clinical research associate, database manager and data support
specialist to direct data flow procedures and ensure database integrity for phase
I-IV studies. Phase III and IV trials. Indications included HIV and AIDS.
• Liaison between site and data management in clinical/technical issues.
• Developed project forms to meet specific project needs
• Coded Adverse Events and Medications
• Developed CRF Completion Instructions, CRF Data Review Guidelines and
consultation for Case Report Form Design.
• Developed Edit Check Logic (validation)
• Data query documentation, resolution and integration
• Primary Contact for clinical data issues
• Additional responsibilities included supervision of study phone center that
required site coordination and site management, supervision and training of phone
center personnel, collection, review and tracking of regulatory documentation and
adverse event reporting.
Carlton Village Retirement / Nursing Home, Bedford, MA. 1990 - 1993
Rehabilitation Aide
• Performed various rehabilitation exercises with cardiac, stoke, hip
replacements/fractures, MS, polio, rheumatoid arthritis and Alzheimer patients.
• Emergency Medical Responder.
GLENDALE FAMILY YMCA, Glendale, CA. 1987 - 1990
Director of Physical Fitness
EDUCATION
Southern New Hampshire University Graduate School of Business 2000 - 2006
Masters of Science Degree, Information Technology
New Hampshire Community Technical College 1999 – 2000
Programming/Database Design coursework
University of Lowell, Lowell, MA. 1990 - 1993
Middlesex Community College, Bedford, MA.
Prerequisite coursework towards M.S., evening school
Springfield College, Springfield, MA.
Prerequisite coursework towards M.S. 1989 - 1990
Bachelor of Science Degree - Exercise Physiology and Minor – Business 1983 -
1987
Graduated Magna Cum Laude and Kappa Delta Pi Honor Society
CERTIFICATIONS and TRAINING
• SAS Base Certification 6/18/2009
• SAS Base Programming II: Data Manipulation Techniques 5/13-5/16/2009
• SAS Base Programming: Programming I: Essentials 5/6-5/8/2009
• CDISC 1/29-1/20/09
• Oracle Clinical TMS, 4.5.3 1/26-1/28/09
• Oracle Clinical RDC, 4.5.3 1/21-1/22/09
• Oracle Clinical Basics, 4.5.3 1/5-1/9/09
• OC Advanced Topics, TMS Advanced Topics, OC Advanced Procedures, 8/2007
• OC Complex Procedures, OC Administration, OC System Structure
• SCDM – EDC Life Cycle 8/2007
• SCDM – Database Design and Validation 1/2006
• Oracle Clinical (4.5.1), Oracle Clinical RDC (4.5.1), Oracle TMS
(4.5.2) 8/15-9/15/06
• Computerized Systems Used in Clinical Trials: Improving Compliance 10/2004
FOI Services online – Sharlin Consulting (Joshua Sharlin, PhD)
• HIPAA 4/2003
• Clinical Project Management in the Pharmaceutical Industry 4/25-4/26/02
• Introduction to Oracle for Experienced SQL Users (PL/SQL) 6/18-6/20/01
• Clintrial 4.1 Design 9/18-9/21/00
• Using Clintrial 4.1 9/13-9/15/00
PROFESSIONAL ASSOCIATIONS
• SAS Users Group
• Society of Clinical Data Management (SCDM)
• Oracle Clinical Users Group (UCUG)
• Clinical Data Interchange Standards Consortium (CDISC)
COMPUTER/SOFTWARE
• SAS9, Oracle Clinical, Oracle RDC, TMS, SQL, Visual Basic, Clintrial, MS/DOS,
Windows, MSACCESS, Word, Excel, MSProject
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