Rajeswari J
About Rajeswari J
Rajeswari J is a Senior Clinical Data Manager with extensive experience in managing clinical trials and expertise in electronic data capture systems. She has worked for various organizations, including PPD, IQVIA, and Fulcrum Therapeutics, and holds advanced degrees in Information Science and Pharmacy.
Work at Fulcrum Therapeutics
Rajeswari J currently serves as a Senior Clinical Data Manager at Fulcrum Therapeutics. She has held this position since 2022, contributing to the management of clinical data and ensuring compliance with industry standards. Her role involves overseeing clinical trials and studies, focusing on phases I to III, which includes study start-up, conduct, and database lock.
Previous Experience in Clinical Data Management
Before joining Fulcrum Therapeutics, Rajeswari J worked at Arcane Systems as a Clinical Data Manager since 2021. Prior to that, she was employed at PPD as a Clinical Data Manager for seven months in the United States and spent a year at IQVIA in India in the same role. She also worked at Bioclinica as a Clinical Data Coordinator from 2017 to 2020.
Education and Expertise
Rajeswari J holds a Master's degree in Information Science/Studies from the University of North Texas. She also earned a Doctor of Pharmacy (PharmD) from Acharya Nagarjuna University. Her educational background supports her extensive expertise in clinical data management and electronic data capture (EDC) systems.
Technical Proficiencies
Rajeswari J has extensive experience with various electronic data capture (EDC) systems, including Medidata Rave, Oracle Inform, Veeva Vault, IBM Clinical, and Medrio. She is proficient in safety databases such as Argus and Aris-G. Additionally, she is knowledgeable in industry standards and guidelines, including CDISC/CDASH, SDTM, AdaM, 21 CFR PART 11, ICH, GCP, GCDMP, and US FDA safety reporting.
Therapeutic Areas of Expertise
Throughout her career, Rajeswari J has worked across a diverse range of therapeutic areas. Her experience includes managing clinical trials in Oncology, Neurology, Rare diseases, Respiratory diseases, Liver diseases, Haematology, and Ophthalmology. This breadth of experience enhances her capability in clinical data management.