SUMMARY:

• 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.

TECHNICAL SKILLS:

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

PROFESSIONAL EXPERIENCE:

Confidential

SAS Application Programmer

Responsibilities:

• 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.

Confidential

Senior Clinical Data Manager

Responsibilities:

• 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.

Confidential

Director

Responsibilities:

• 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.

Confidential

Director

Responsibilities:

• 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.

Confidential

Senior Developer

Responsibilities:

• 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.