Gian Paolo MacHado

About Gian Paolo MacHado

Biomedical researcher interested in clinical research and development.

Experience

1. Precision Medicine Operations Lead

   Parexel

   Sep 2023 — Present

   Program management: Study team support and cross functional stakeholder guidance for Hemophilia B and NASHo Participate with sponsor clinical study team to support study start-up activities including development of study protocol, ICF, and various clinical documents concerning biosampleso Manage operational aspect of clinical sample acquisition from beginning to end of study and serve as point of contact for sample transaction and useo Initiate and oversee contracting and monitor vendor activities to ensure scope and budget plans are met • Companion Diagnostics oversight: CDx sample and vendor managemento Oversee CDx aspect of sponsor’s cell and gene therapy study portfolio to assure GCP compliance with regulatory authorities under the scope of clinical samplingo Collaborate with third party vendor to carry out monitoring visit and review monitoring metrics, protocol deviations, quality issues, and push for action item follow through to ensure accuracy and integrity of data.

Skills

• Pharmaceutical Industry
• Sop
• Gmp
• Glp
• Fda
• Analytical Chemistry
• Research
• Chromatography
• Biotechnology
• Validation
• Hplc
• High-Performance Liquid Chromatography (Hplc)
• Standard Operating Procedure (Sop)
• Research and Development (R&D)
• Good Laboratory Practice (Glp)