Susan M Castellino

Freelance Data Entry Freelancer & Database Designer

816
Location:New York, New York, United States
Profile:https://www.freelanced.com/susanmcastellino
0
Kudos
3.5
2 Skills
$20
Rate/Hr
Objective
Obtain a part-time position, or a part-time/full-time telecommuting position, where I can utilize my extensive knowledge of clinical data management in a collaborative team working environment.
Summary
Highly effective, efficient data manager with over 10 years experience in clinical data management, analysis and supply chain. Focused on the details and importance to having accurate data for reporting and reacting accordingly with team and organizational objectives. Achieved Master of Science in Information Technology specializing in Health Information Management Systems.
Detailed Experience
Clinical Data Analyst II
Boston Scientific Marlboro, MA 2011 - preset
• Increased responsibilities with regard to tracking of data issues and trends
• Monitor and track site discrepancies, following through to resolution
• Provide increased input for job aides to assist training of new team members
• Developed relationship with an internal business group for a global collaborative work-force
• Increased responsibilities with development, coordination, and close-out procedures for system User Acceptance Testing
Senior Clinical Trial Coordinator
Boston Scientific Marlboro, MA 2009 - 2011
• Perform device accountability of all available and expiring devices
• Conduct expiring device return coordination with warehouse
• Conduct shipments of devices to clinical trial sites
• Verify sites have accurate numbers of devices and update database accordingly
• Assist with tracking and filing of study documents
• Coordinate the processing of device usages in the database, and completing reconciliation by ensuring clinical study sites are resupplied accurately
• Create spreadsheets to track devices shipped, used, and returned
• Liaison with internal team members and outside vendors
• Develop spreadsheets to track study metrics and device inventory levels
Senior Clinical Trial Coordinator, for Boston Scientific
Conexis Resource Partners Marlboro, MA 2008 - 2009
• Perform device accountability of all available and expiring devices
• Conduct expiring device return coordination with warehouse
• Conduct shipments of devices to clinical trial sites
• Verify sites have accurate numbers of devices and update database accordingly
• Assist with tracking and filing of study documents
• Coordinate the processing of device usages in the database, and completing reconciliation by ensuring clinical study sites are resupplied accurately
Assistant Consultant – Data Management
Boston Biomedical Associates Northboro, MA 2008 - 2008
• Create study setup information for database, including all test documents
• Create CRFs
• Create Data Management Plan
• Perform query integration and generation
Senior Clinical Data Manager
Averion International Southboro, MA 2007 - 2008
• Perform data review and verification
• Conduct data preparation of CRFs
• Update Data Management Plan
• Perform query integration and generation
• Conduct laboratory reconciliation
• Perform Subject Closure reports
Clinical Data Specialist
Cytyc Corporation Marlboro, MA 2004 - 2007
• Upon 1 year anniversary, promoted from Clinical Data Associate to Clinical Data Specialist
• Data verification on all studies
• Produce data management documentation including Data Management Plans,
Validation Procedures, and Work Instructions
• Developing Cytyc’s Data Management Training curriculum
• Assist Manager with auditing of several studies
• Assist Manager and Director of Clinical Affairs with the locking of studies
• Archive old data records and maintain record keeping of those archived folders
• Perform study setup of all incoming studies
• Assist Clinical Data Associate with CRF Design and Edit Check definitions
• Respond to questions regarding CRF completion (CRAs and Study Site Coordinators)
• Produce study reports as requested by team
• Update CRF Completion Guidelines for ongoing studies
• Create CRF Completion Guidelines for new studies
• Assist Manager with preparation of data for the DSMB meetings
Clinical Data Manager
PAREXEL, International Waltham, MA 2002 - 2004
• Assisted Query Lead with prepping, sending, and receiving of CRF data queries
• Assist team with query integration
• Query Lead
• SAE Lead
• Electronic Data (Lab/ECG) Lead
• Resolution of Medical Review Listings
• Developed SQL scripts to search CRF for data
• Assist Database Manager with loading of electronic data from FTP file to VMS server
• Assist Data Managers with auditing of CRF data
• Perform CRF data checks daily to meet set metrics
• Assist Primary CDM with data point listings
• Assisted Coding Lead with coding of Adverse Event terms

Education

MS IT in Health Information Management Systems
Capella University Minneapolis, MN 2012
4.0 GPA
Graduate Certificate in Clinical Trials Management
Thomas Edison State College Trenton, NJ 2008
4.0 GPA
Bachelor of Science, Wildlife and Fisheries Science
Eastern New Mexico University Portales, NM 1998
3.0 GPA
Skills
• Highly organized
• Strict attention to details
• Team player
• Quick learner
• Extensive knowledge regarding data management and clinical trial management
• Experienced on Windows, Mac OS X and UNIX operating systems
• Proficient with SAP, MS Office, DataFax, Siebel CTMS, Medidata Rave, InForm, various third-party IVRS/IWRS systems
Skills (2) Rating
Data Entry
Database Design