Aishwarya Amresh Patil

About Aishwarya Amresh Patil

Experienced Clinical Trial Specialist with a passion for advancing clinical research and improving patient outcomes. With over 4 years of hands-on experience managing global pivotal trials from Phase I to Phase I\'ve developed a strong foundation in both clinical research and regulatory affairs. My expertise includes: Implementing study protocols and managing site operations Developing effective patient recruitment and retention strategies Ensuring regulatory compliance (GCP, ICH, FDA regulations) Managing data integrity using EDC systems and eCRFs Conducting site initiation, monitoring, and close-out visits Overseeing adverse event reporting and safety monitoring Maintaining comprehensive Trial Master Files (TMF) Contributing to regulatory submissions (IND, NDA, BLA) Collaborating effectively with cross-functional teams I\'m proficient in electronic data capture systems like Medidata Rave and Veeva Vault, clinical trial management systems such as OnCore, and the Microsoft Office Suite. My experience spans developing and maintaining essential study documents, including protocols, ICFs, and regulatory submissions. My educational background includes a Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University, building upon my Doctor of Pharmacy degree. I\'m also CITI and SCRS certified. I\'m always eager to take on new challenges that allow me to apply my clinical research and regulatory affairs expertise to drive innovation in healthcare and make a meaningful impact on patients\' lives.

Experience

1. Senior Digital Health Specialist

   N-Power Medicine, Inc.

   Present