Aprajita Saini
About Aprajita Saini
Aprajita Saini is a Clinical Trial Manager with extensive experience in clinical research management and a strong background in biology. She is currently pursuing a PMP certification and has worked at various organizations, including Day One Biopharmaceuticals and Bioclinica.
Work at Day One Biopharmaceuticals
Aprajita Saini has been serving as a Clinical Trial Manager at Day One Biopharmaceuticals since 2022. In this role, she is responsible for overseeing clinical trials, ensuring compliance with regulatory requirements, and managing study-specific manuals and reference guides that detail protocols and procedures. Her position involves facilitating communication among cross-functional teams, clients, and third-party vendors to ensure the smooth execution of clinical studies.
Education and Expertise
Aprajita Saini earned a Master of Science in Clinical Research Management from Wake Forest School of Medicine, completing her studies from 2020 to 2022. She possesses a strong background in biology, with knowledge in systemic physiology and cell biology. Currently, she is pursuing a Project Management Professional (PMP) certification to further enhance her project management skills.
Background in Clinical Research
Aprajita Saini has extensive experience in clinical research, having worked in various roles across multiple organizations. She began her career at Bioclinica as a Clinical Operations Associate from 2015 to 2016 and progressed to roles including Clinical Project Manager and Associate Clinical Project Manager II until 2018. She also worked at Iovance Biotherapeutics, Inc. as a Clinical Research Associate from 2018 to 2019, and at Exelixis as a Sr. Imaging Analyst and Technical Operations Imaging Manager from 2019 to 2021.
Clinical Trial Management Skills
Aprajita Saini is experienced in drafting study-specific manuals and reference guides that outline clinical trial protocols and procedures. She is familiar with various clinical management systems, including web-based Electronic Data Capture (EDC), electronic Case Report Forms (eCRFs), electronic Common Technical Document (eCTD), Interactive Voice Response Systems (IXRS), and Electronic Medical Records (EMR). Her knowledge of FDA regulations, Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) guidelines, and Institutional Review Board (IRB) requirements supports her effective management of clinical trials.