Hareesh Jonnalagadda

About Hareesh Jonnalagadda

Expertise in working with study start-ups, conduct and close-out activities of clinical trials to deliver clean and quality data. • Competent to work under tight timelines and strict deliverables, ability to resolve issues and meet deadlines. • Reviewed and provided input to the study protocols to ensure that the data collection requirements are clear and supportive of the study endpoints. • Proficient in e-CRF design specification, Edit check creation, data cleaning and query process, SAE reconciliation and lab data reconciliation. • Efficient in Designing Case Report Forms (CRFs), Data Management Plans (DMPs), Data Review Plan (DRP) and performing User Acceptance Testing (UAT). • Strong working knowledge of GCP, CDASH, and CDISC data structures, 21 CFR Part 11, ICH guidelines, and FDA regulations. • Experience in working with various EDC systems (e.g, Oracle Clinical, Inform, Medidata Rave), Argus platform, and general understanding/use of SAS and BI data Visualization. • Expertise in CRF tracking, database QC and database audit. • Experience in developing an Interactive Web-Based Randomization System (IWRS). • Therapeutic experience in Cardiovascular disease, Oncology, Immunology and Respiratory Diseases. • Oversee performance of CROs, third-party vendors, and field CRAs including monitoring, to ensure compliance with the study protocol. • Experience in Data reporting tools such as Jreview.

Experience

1. Lead Clinical Data Manager

   AbbVie

   Oct 2022 — Present · US

Education

• Krishna University, Machhlipattanam

  Bachelor of Pharmacy - BPharm, Pharmacy