SAM ORCUTT

• Assisted Clinical Data Manager by programming SAS Edit Checks, External Data Reconciliation, Clean Subject Reports, Patient Profiles, Medical Coding and other custom programs
• Experienced in defensive programming practices such as producing Warnings for data that has not yet been programmed on, or indicating whether new data received requires a change to the merge variables
• Performed QC of programs developed by other SAS programmers. Followed good programming practices and adequately documented with comments throughout
• Used SAS to import/export into other data file formats, such as Word, Excel, PDF, CSV
• Highly seasoned troubleshooter on SAS issues related to programming errors or connectivity errors. Worked closely with Clinical Data Managers on assisting their programmatic needs, and troubleshooting issues for them
• Implemented an error log check so Clinical Data Managers do not need to view the SAS log. They can also run a SAS program using non-SAS software DAT
• Mentored employees to successful completion of SAS programs, and new hire phase, generally one employee at a time
• Set up new studies with a Data Management-Initialization program. Set up all libnames, options, and macro calls. This program was updated throughout the study with new macros, etc.

• Assisted Clinical Data Manager by programming SAS Edit Checks, External Data Reconciliation, Clean Subject Reports, Patient Profiles, Randsamps, Varcounts, and Database Reliability programs
• Study Data Tabulation Model (SDTM) programming based on CDISC guidelines
• Programmed Site Payment Reports based on sponsor specifications, and attended sponsor based meetings to explain practices
• Performed QC of programs developed by other SAS programmers. Followed good programming practices and fully documented programs
• Used SAS to import/export into other data file formats, such as Word, Excel, PDF, CSV
• Hands on troubleshooting SAS issues related to programming errors or connectivity errors
• Mentored employees to successful completion of SAS programs, generally 1-2 employees at a time

• Maintained a database accuracy record of a minimum 99.88% at database close when acting as Lead Data Manager

• Designed and developed Case Report Forms based on the study protocol

• Developed and QC’d database structures, formats, test data, electronic and manual edit checks, query forms, data conventions, and data entry instructions

• Validated and reviewed clinical trial data using DataFax 3.9.1, ClinTrial 4.4, SynCapture, and SAS 9.1

• Ensured database accuracy through development and review of edit checks, data queries, and identification of data trends within clinical databases

• Communicated with Study Sponsors, Vendors, Central Labs, and Clinical Monitors on CRF, database, and study issues, provided data management support

• Generated customized reporting methods and delivered status reports of database metrics to assist study sponsors to meet their budgets as well as timeline, accuracy goals, and to identify site or monitor training needs

• Trained new employees, study team members, and CRAs on data management processes, SOPs and clinical software including DataFax, ClinTrial, and SAS as it relates to data management and specific study protocols

• Created customized SAS and SQL data listings identifying data trends and quality or integrity inconsistencies in order to provide a more accurate database, identify site training needs, and refine edit check programming

• Coordinated work flow between internal departments and vendors including Clinical, Programming, Project Management, Safety, Medical Coding, Statistics, Central Labs, Clinical Sites and CRAs

• Developed patient data profiles using SAS, conducted 100% critical data audits, 10% all data audits, and developed programs to calculate database accuracy rates

• Developed and maintained hard copy and electronic study documentation, and defended documentation practices during an audit

• Conducted process specific departmental training, and participated in the bid defense of new projects for potential sponsors

• Successfully integrated external data transfers, performed quality control steps and reconciliation of central lab data, serious adverse events, screen failures, and randomization databases

• Managed up to seven clinical trials concurrently including Phase I, II, and III studies using DataFax, ClinTrial, SynCapture, and SAS software, including the management of study team members of up to six employees while maintaining high levels of quality, database accuracy, and customer satisfaction

• Served on Data Management and Database Development efficiency committee to improve efficiency and procedures throughout the department

Awards and Recognition

• JAN2007 Employee Recognition award for Outstanding Dedication

• DEC2007 Nominated by peers for recognition in the category Quality

• DEC2007 Nominated by peers for recognition in the category Productivity

• DEC2008 Nominated by peers for recognition in the category Responsiveness

Certificates

• JAN2008 InForm 4.5 for CDMs

• AUG2008 Beginner Data Management SAS Course I

• SEP2008 InForm 4.6 CDM – Modules

• Developed database structure, and customize variables, formats, data fields and data entry screens based on client specifications using SAS
• Developed custom edit checks based on CRF, and programed edit checks using SAS. Reviewed edit check output for query generation and data review
• Developed custom database metrics reports using SAS
• Secondary data entry and discrepancy resolution of clinical trial data using SAS
• Developed custom methods of calculating data entry accuracy rate for each employee to identify trends and areas for improvement
• Reviewed results of database audits, identified database accuracy rate, and compiled audit reports prior to database lock
• Coordinated work flow between internal departments including Clinical, Programming, Statistics, Project Management, and external Central Labs
• Trained internal teams, clients and sponsors on in-house built database systems, data entry process, reconciliation of first and second pass data entry, programming metrics reports, and SAS data listings
• Data Entry of clinical trial data into customized clinical database, completing first or second pass data entry for 50-300 Case Report Forms per day
• Reconciliation of first pass and second pass data entries by identifying duplicate records, key variables, and proc compare

• Conducted telephone job market research with San Diego employers including small, medium and large employers with 500+ employees
• Trained and supervised employees on job market research survey techniques
• Packed and shipped pharmaceutical drugs in pharmacy warehouse environment
• Data entry of clinical trial CRF data

• General filing, faxing, and preparation of documents for meetings and presentations
• Assisted in the resolution of medical billing discrepancies through research of Explanation of Benefits and Accounts Payable/Receivable database
• Greeted patients and assisted with the registration of new patients using a demographic database
• Data entry of medical patient data using customized medical billing software
• Assisted Medical Billing Professionals to achieve monthly collection goals by providing general administrative support