Peter Gerhardt Email & Phone Number

Raritan, Nj, Us

Manage the clinical data management group consisting of permanent and contract employees. Liaise with study leads to plan and update data management resources on an ongoing basis. I am accountable to ensure that study deliverables and timelines are met and that a sound project management and resource planning methodology is in place. Researched and identified a Clinical Data Management System (CDMS) and led the team to configure and validate the system. Review and provide input to CRF design and CRF Completion Instructions, review database design and provide input into Data Management / Data Validation plans and data entry guidelines. Accountable for the CDMS Process and the development of SOPs for the group. Monitor the quality of Data Management processes, CDMS, and data quality and advise and implement improvement where necessary. Build Oracle Clinical and Medidata Rave EDC study databases as needed. Participated in a cross Johnson and Johnson team to identify and implement an Electronic Data Capture system to be shared amongst operating companies. Provided SAS programming support for trial monitoring and final analysis.

Raritan, Nj, Us

Designed and programmed clinical trial databases and the analysis of the data. Databases were programmed using SAS AF, SAS FSP and SAS Base as well as PC DBMS such as Paradox. Wrote SAS programs to capture output from lab instrumentation. The analysis of the clinical databases were programmed using SAS Base, Graph, QC and Stat. All analysis included routines to identify errors in the databases caused by improper data entry, protocol noncompliance and transcription errors. Responsible for sourcing, managing and coordinating daily activities of contract SAS programmers in order to meet project deadlines and goals. Managed and coordinated the development of SOPs and working instructions for SAS study specific program validation, and data entry application validation. Provided input and guidance in the development of a data entry application that is compliant with CFR 21 part 11. Represented Clinical Affairs on multi department team in obtaining Safe Harbor Certification. Worked with clinical study teams in preparing RFPs from CROs including data management and programming specifications. Oversaw deliverables from CROs including database lock. As a member of Clinical Trial teams attended team meetings contributing in areas of programming and data management, as well as study design and execution. Supported FDA BIMO audits of Clinical Trials as well as internal audits of department process and SOPs.

Perform quality reviews of clinical programmer’s deliverables including data listings, summary tables and analysis datasets programmed using SAS software. Using quality review data, identify areas for process improvements and work with teams to implement the improvements. Served as member of Study specific program validation team, and authored SAS programming standards document. Performed testing and validation on various database tools and utilities including standard Clintrial templates and SAS macros used to identify data entry errors.

Raritan, Nj, Us

Designed and programmed clinical trial databases and the analysis of the data. Databases were programmed using SAS AF, SAS FSP and SAS Base operating under VMS as well as PC DBMS such as Paradox. Many of these databases were created by capturing ASCII output from instrumentation and writing SAS code to accept this data. The analysis of clinical databases were programmed using SAS Base, Graph, QC and Stat. All analysis include routines to identify errors in the databases caused by improper data entry, protocol noncompliance and transcription errors. Additional responsibilities include the daily system administration of a VAX clustered system operating under VMS, and a department LAN using Digital Pathworks. Recommended and implemented moving SAS from the VMS platform to a PC platform which resulted in increased productivity.