Monday, July 20, 2009

Elevator Speech

An "elevator speech" is the 30-seconds you have to introduce yourself to a potential employer while running into them in an elevator. Many of us have developed and practiced this speech regarding the importance and status of projects we have worked on in our professional life, but now it needs to be adjusted to reflect our new goal to market ourselves in order to obtain a new challenging assignment or employment opportunity.


It is important that your elevator speech conveys who you are, what you do, what you’re seeking and any other key information relevant to your experience or job search goals.



Who am I?


I have over 20 years of experience as an IT professional developing analytical solutions supporting the clinical and scientific communities within the Pharmaceutical, Medical, and Public Health industries. I am passionate about contributing to the development and approval of new drug treatments and therapies and enjoy engaging the business and scientific communities to help implement new automated solutions that improve our ability to combat disease and treat patients.



What am I?


I am an IT professional specializing in SAS software development that is capable of acquiring and manipulating clinical, medical, and scientific data for visualization and reporting purposes. I continue to explore new ways that will improve the process and tools used to generate regulatory reporting of clinical research data.



What I am seeking?


I am seeking the opportunity to apply my knowledge and experience working with clinical and medical data within the Pharmaceutical, Biotechnology, and Medical Research community.



Other key information relevant to your experience or job search goals.


  • Over 20 years as a SAS programmer working with Clinical, Medical, and Public Health research data

  • Capable of accessing Oracle Clinical tables and views and writing back to Oracle tables using SAS

  • Industry Medical Dictionaries: MedDRA, ICD9, and BNF and WHO Drug Dictionaries

  • Industry Data Standards: CDISC, ICH

  • Trained and implemented GCP regulatory requirements

  • 21 CFR Part 11 Compliance – implementation of dependency and revision control to manage the traceability of artifacts in the generation of clinical reports

  • Business analysis and process modeling experience

  • PMP Trained Project Management and documentation required to ensure quality through all phases of the Software Development Life Cycle: Idea/Charter, Business and Functional requirements, Design, Implementation/Build, Test, Deploy, and Uptake

  • Improving the exchange of information and knowledge by leveraging business Collaboration Tools such as SharePoint, Documentum, and SourceForge

  • Software engineering revision control and configuration management tools such as RCS, CVS, and Subversion

Professional Experience



  • Clinical Reporting Subject Matter Expert (SME) and Technical Team Lead in developing the 21 CFR Part 11 compliant clinical reporting system called CDARS at Pfizer

  • SME responsible for the development of generic clinical reporting software at Pfizer in support of Annual Safety, Investigator Brochures, Clinical Study, and NDA regulatory reporting

  • Developed Integrated Safety and Efficacy Summary data and reporting

  • Ability to extract and translate clinical trial safety, efficacy, and protocol registry data from Oracle Clinical using SAS so that it can be easily reviewed by clinical teams using Tibco Spotfire, Pipeline Pilot and Excel

  • Re-engineered Safety and Risk Management Protocol Registry Brio Query Periodic Safety Update Reporting using SAS in the CDARS environment

  • Deployed the Genologics Lab Instrumentation Management System (LIMS) in support of Pharmacogenomic research - Currently collaborating on a white paper detailing the complexity of deploying a LIMS solution within a shared server environment that is both GLP and GCP compliant

  • Re-engineered a complex Web-based J2EE / Oracle application that managed and tracked clinical biomarkers using functionality within SharePoint - This effort resulted in a $125K annual reduction in application support costs and empowered the Translational Medicine / Biomarker communities to independently manage the content and access to this critical data

1 comment:

  1. Thanks for sharing this much interesting and nice information with us. Awesome post...

    ReplyDelete