Lavanya KC

I was appointed as the Business Solution Lead for the Asia Pacific Investigator Contract Solution (APICS) IQVIA team on 12/01/22. My role involves overseeing and facilitating the initiation of all necessary contracting activities for designated sponsors, studies, or multi-protocol programs based on the agreed algorithm or Sponsor’s specifications, including pre-award tasks. I also provide guidance on contracting language and extend assistance to other Regional Investigator Contract Analysts. With over 9 years of experience in Clinical Research and 2 years in Teaching, I have served as a Senior Project Associate in Clinical Research for 3 years, a Site Start-up Specialist for 4 years at Quintiles from Aug 2005 to May 2012. I rejoined Quintiles on 02/24/21 as a Records Management Analyst in the RIM team for 1 year and 8 months. My expertise includes in-house support for Clinical Research Associate/CTL, maintaining and reviewing in-house files, startup activities such as translations and EC submissions, coordinating with sites, preparing IP packets, maintaining tracking logs, archival, in-house audit preparations, IM preparations, newsletters, and providing training for Project Associates.

Phase 2, Rheumatoid Arthritis, Project Assistant, Training other Project Associates and new team members. In-house support for Clinical Research Associate/CTL. Maintaining and periodic review of in-house files. Start-up activities like Translations, Ethics Committee Submissions. Co-ordination and correspondence with sites. Preparing Investigational products Packets. Maintaining tracking logs. Archival. In-house Audit Preparations. Investigator’s Meeting preparations. Newsletters preparation.

• Rheumatology, 1.5, Training other Project Associates and new team members. In-house support for Clinical Research Associate/CTL. Maintaining and periodic review of in-house files. Start-up activities like Translations, Ethics Committee Submissions. Co-ordination and correspondence with sites. Preparing Investigational products Packets. Maintaining tracking logs. Archival. In-house Audit Preparations. Investigator’s Meeting preparations. Newsletters preparation
• Rheumatoid Arthritis, 1.0, Training other Project Associates and new team members. In-house support for Clinical Research Associate/CTL. Maintaining and periodic review of in-house files. Start-up activities like Translations, Ethics Committee Submissions. Co-ordination and correspondence with sites. Preparing Investigational products Packets. Maintaining tracking logs. Archival. In-house Audit Preparations. Investigator’s Meeting preparations. Newsletters preparation

• Clinical, Feasibilities, Yes
• Clinical, Reg Body and/or Ethics Comm Submissions, Yes
• Clinical, Study Files Maintenance, Yes
• RSU, RSU Within Quintiles, 1-3
• RSU, Asia, 1-3
• RSU, Feasibility Experience, Yes
• RSU, Contract Negotiation, Yes
• RSU, Preparation of Regulatory Authority Submissions, Yes
• RSU, Preparation of Ethics Committee Submissions, Yes
• RSU, Collection and Review of Regulatory Packages, Yes
• Records Management, Intelligent TMF, 1-3
• Records Management, IQVIA Wingspan, 1-3
• Records Management, QC, 1-3

Budget Solution Lead

Budget Solution Lead

India

• 05/2003, DON BOSCO COLLEGE OF SCIENCES AND MANAGEMENT, India, Master of Science, Biotechnology, Completed
• 05/2001, CHRIST COLLEGE, India, Bachelor of Science, CBZ, Completed

GCP certification exam, 2022

• Kannada, Fluent, Fluent, Fluent
• Hindi, Fluent, Fluent, Fluent
• Telugu, Fluent, Basic, Basic