Swaidha S. Email & Phone Number

Swaidha is working as an Associate Lead in Centralized Monitoring since Sep 2019. She has over 9+ years of clinical research experience. She has been a CRA and Senior Remote Monitor trainer in her past organizations. She has handled clinical trials in multiple therapeutic areas. She has experience in all activities pertaining to regulatory startup, preparing the study for QA Audits, perform file review and QC of review, investigator payment activities and remote CRA role such as CTMS management, eTMF management, reviewing the lab and eCRF data, raising queries, reviewing ICFs and SAEs and reconciliation, access management etc. She has also handled sponsor audits for her studies. She has trained candidates both regional and global from beginner to senior level, on various aspects of Clinical Research such as ICH GCP, Global Regulatory Requirements, Monitoring practices, EDC and various other company relevant processes.Value she brings on the table:• Unique experience of Clinical Operations, Risk Based Monitoring, Data Analysis and UAT - skills that will help her add value to business productivity, process improvement initiatives and quality-oriented output.• Strong UAT experience for Life Sciences Applications (Argus, eTMF and CTMS) including test case authoring, execution, and review. • Detail oriented with excellent communication skills and collaborative approach.• 7 years experience in CTMS.• 2.5 years experience in CSV.

Listed skills include Ich Gcp, Clinical Research, and Risk Based Monitoring.