- Accomplished Pharmaceutical Technology Management and Programming Professional with expertise in SQL, SAS, Programming, Reporting, Database Development, eCRF creation and Clinical Data Management.
- Diverse experience in pharmaceutical research (pre - clinical and human trials), startups and large corporations.
- Proven ability to manage end-to-end delivery of multiple projects through the full data management lifecycle ensuring consistent data handling and quality in compliance with GCP and GLP regulations.
- Managed imaging clinical data management team that produced results that were reproducible and cost-efficient.
- Expertise in the SDLC of systems and processes in the facilitation of data collection and extraction projects, as well as change management and corrective actions.
- Extensive experience in complex stored procedures and embedded procedures using SQL.
Microsoft TSQL Programming: views, stored procedures, and triggers
Microsoft SSRS: Reporting Services, Crystal Reports 8.5
SAS Programming: creating datasets to export requirements; edit check programming; SAS/ACCESS component:VB.NET and C# Visual Studio 2005, 2008, and 2010
Medidata: Rave, Medrio
SAS Application Programmer
- Responsible for list population creation from banking credit card systems for advertising and internal utilization using SAS, Unix, PostgreSQL and Teradata.
- Creation of population lists meeting requirements as provided by marketers and business analyst.
- Reviewed training materials and provided comment and recommendation for improvement.
Senior Clinical Data Manager
- Assisted with the creation of Case Report Forms (CRFs) and database design using Medrio and Rave.
- Created and validated edit checks.
- Developed study documentation, such as the data management plan, manual review guide and data entry guidelines.
- Oversaw data review and query generation for data cleaning practices.
- Managed a group of three database developers in the creation and generation of client deliverables using internal data transformation engine, SQL and SAS.
- Assisted with practice and onboarding of JReview as an integrated review tool with SureSource portal.
- Created standard reports with dynamic connection string across different schemas using SQL Server 2012, TSQL.
- Responsible for the IVRS integration team during a division downsizing, while retaining key staff members.
- Implemented proactive quality management plans across multiple projects/programs.
- Tracked service performance and provided leadership to identify root causes of issues and implement remedial actions.
- Reduced overall error rate for IVRS integration programmers by more than 50%.
- Utilized Spotfire for several Phase I medical affairs presentations.
- Created weekly tracking reports for sponsor utilization and metrics tracking using SSRS and TSQL.
- Primary point person on data management deliverables. Highest level accountability for all sponsors and handled escalated issues as needed.
- Implemented an edit check process using SAS, and a ticket system for work requests improving response rates by 38%.
- Planned, developed and executed the migration from base SAS to SAS Enterprise Guide and SQL Server.
- Implemented usage of SAS and SAS Access OLEDB for delivery creation.
- Implemented edit check process using SAS against the study deliverables.
- Reviewed and approved study-specific procedures applicable to the department. Responsible for departmental SOPs.
- Implemented the usage of Oracle Life Science Data Hub (LSH) for RECIST studies.
- Implemented usage of C# .NET as standard programming language for custom software development.
- Generated initial version of project management system using ASP.NET that later evolved into the Clinical Trial Management System (CTMS).
- Project included the design and creation of the database, store procedures and views utilizing SQL Server 2005.
- Created standard audit trail practice for eCRF databases using a custom trigger on database tables.
- Created eCRF collection systems using C# and SQL based on provided requirements.
- Programmed, tested, and documented databases in accordance with programming standards and validation procedures.
- Led the creation of the Time Phasing application for realization of lab revenue using Visual Basic 6.0 resulting in the capture of an additional $9M in monthly revenues. Project included backend database design, table creation, views and stored procedures.
- Developed a reporting functionality using Crystal Reports 8.5 as a member of the eNotes Intranet application project.
- Designed an FDA Price screen using OLE drag and drop methods with a file explorer format.
- Automated instrument collection methods from Hematology, Urinalysis and Electrophoresis lab equipment.
- Contributed to Y2K remediation of legacy system applications on HP3000 system and PowerHouse 4GL programming environment.
- Provided support to in house Laboratory Information Management System (LIMS) and Metrology systems.
- Developed instrument interfaces and internal systems using Visual Basic 6.0, C#.Net and SQL Server.