Amit Patel

About Amit Patel

Accomplished Site Activation Manager with over 19 years of extensive experience in clinical research and project management, specializing in study start-up, regulatory compliance, site activation, and risk management. Held various key roles including IH-CRA, CRA, Senior Specialist GSS, eTMF Specialist, and SUPM. Demonstrated success in leading cross-functional teams and delivering complex global clinical trials. Managed the complete start-up cycle for numerous clinical studies across various therapeutic areas, including oncology, neurology, cardiometabolic diseases, and immune-mediated inflammatory conditions, ensuring timely execution and regulatory compliance. Expertise in developing and executing strategies to ensure on-time site activation, regulatory submissions, and efficient project timelines. Skilled in managing client relationships, optimizing operational efficiencies, and ensuring high standards of quality and compliance. Strong leadership skills with a focus on driving continuous improvement, reducing risk, and ensuring successful project outcomes through collaboration and proactive issue resolution.

Experience

1. Sr Regulatory Submissions Manager

   Medpace

   Mar 2025 — Present · Navi Mumbai, IN

Education

• AISSMS College of Pharmacy

  B.Pharm.

  2001 — 2005

• Academy for Clinical Excellence

  Post Graduate Diploma in Clinical Research

  2006 — 2007

Skills

• Clinical Research
• Sop
• Ich-Gcp
• Oncology
• Pharmacovigilance
• Etmf
• Gcp
• Clinical Monitoring
• Clinical Trials
• Clinical Development
• CRO
• Clinical Data Management
• Edc
• Ctms
• Regulatory Submissions
• CRO Management