Overview:

Mr. Guirguis is a clinical research professional who has worked with implantable medical devices since 2005. He has experience with pre-market, post-market, domestic and global clinical trials across various therapeutic areas including vascular disease, electrophysiology, oncology, cardiovascular, neuroscience, endocrinology and gastroenterology.

Mr. Guirguis entered the regulated clinical research industry in 2007 as a Field Clinical Engineer for a small medical device startup investigating their novel implantable device. Similar to a Clinical Research Associate (CRA), he gained extensive experience with regulations, site management, site initiation, IRB management, patient recruitment, device accountability and data management. In addition, he was also responsible for site compliance by training sites on the technology at initiation, being present during surgical cases and being present during subject follow up visits.

Following his field experience, Mr. Guirguis served as a Clinical Project Manager for Novella Clinical and was responsible for the conduct of multiple clinical studies across various therapeutic areas including medical device. His projects have endured multiple quality reviews, including an international inspection by the MHRA which concluded with no major findings. Mr. Guirguis was also responsible for spearheading efforts to streamline the organization and presentation of operational analytics to improve efficiency of clinical teams. During his tenure at Novella Clinical, Mr. Guirguis was recognized as the first project manager to ever be awarded the President’s Award.

Most recently, Mr. Guirguis works for Sapheon, another small medical device company as their Clinical Program Manager supporting the clinical investigation of their implantable medical device. During this time, Mr. Guirguis was ultimately responsible for managing the overall conduct and quality of all clinical activities and vendors. This included undergoing consecutive due diligence reviews from each of the two corporate mergers as well as successfully completing a BIMO audit by the FDA with no findings or observations. Sapheon was eventually purchased by Covidien, which was subsequently purchased by Medtronic. The VenaSeal device was approved by the FDA in February 2015.

Mr. Guirguis received his Masters of Science in Biomedical Engineering from Duke University in Durham, NC. He is a Certified Clinical Research Professional by SOCRA and is certified by the IBHRE as a testamur for cardiac pacing and electrophysiology.

Check out my Experience!

• Professional
• Clinical
• Academic

Certifications:

• Certified Clinical Research Professional (CCRP)
• IBHRE Testamur (formerly NASPExam)
• Engineering Intern (NC FE Exam)

Other Skills:

• General Computing
  • Windows Mac OS, Unix
  • MS Office, Adobe
• Computer Programming
  • VBA, PHP, PERL, HTML, JavaScript, CSS, SQL, Matlab, SAS
• Web Development, Graphic Design
• Document Publishing
• Troubleshooting and Repair
  • Computers
  • Home and Automotive
  • Electronics