Irene Lea
About Irene Lea
Irene Lea is the Senior Manager of Clinical Data Management at Silk Road Medical, Inc., with extensive experience in managing clinical trials across various therapeutic areas.
Current Role at Silk Road Medical, Inc.
Irene Lea is currently serving as Senior Manager Clinical Data Management at Silk Road Medical, Inc. in the United States. In her role, she oversees and manages clinical data activities, ensuring the accuracy and integrity of data collected during clinical trials.
Previous Positions at Silk Road Medical, Inc.
Before her current position, Irene Lea worked as Principal Clinical Data Manager at Silk Road Medical, Inc. from 2021 to 2022. During her tenure, she was responsible for managing clinical data for various studies, contributing to the company's clinical data management strategies.
Experience at Loxo Oncology at Lilly
Irene Lea joined Loxo Oncology at Lilly as a Clinical Data Management Consultant from 2020 to 2021. Based in South San Francisco, CA, she consulted for five months, where she managed clinical data projects and ensured compliance with regulatory standards.
Roles in Various Clinical Data Management Positions
Irene Lea has held multiple positions in clinical data management, including roles at Gilead Sciences, Eyenovia Inc., and Forty Seven Inc. Her responsibilities ranged from CDM Contractor at Gilead Sciences for two months to Clinical Data Management Consultant at Eyenovia Inc. for six months. At Forty Seven Inc., she served as a CDM Consultant for two years in Menlo Park, CA.
Technical Writing Background
Irene Lea has a rich background in technical writing, having worked as Senior Technical Writer at webMethods (now Software AG) from 2000 to 2006. Her technical writing skills are evidenced by her authorship of departmental SOPs, WIs, and other study-related documentation.
Educational Background
Irene Lea holds a Bachelor of Arts - BA from Virginia Tech and has studied at the University of Maryland College of Journalism for her graduate studies. Her strong educational background has provided her with comprehensive skills in both clinical data management and technical writing.
Expertise in Clinical Data Management
With extensive experience in managing clinical trials across various therapeutic areas, including oncology, cardiovascular, and ophthalmology, Irene Lea is adept at utilizing multiple EDC systems such as Medidata Rave, Oracle InForm, IBM Clinical Development, and iMednet. She has also provided direct oversight of CROs and managed a small team of Clinical Data Managers.