Sharath Vuppeti

About Sharath Vuppeti

Total of 12 years of progressive experience as Clinical Research Professional in the Healthcare Industry and in TMF having 11.3 years of experience and current assignment is as Senior TMF Lead at ICON in Veeva Vault, Wingspan & Pfizer TMF platforms and providing training and mentoring to onboarding TMF Leads.Responsible for the complete and accurate Trial Master Files through documentation of quality, consistency and timely filing across all assigned clinical trials.• Responsible to ensure that the clinical trial documentation is consistent with the Trial Master File specifications, applicable SOPs, ICH/GCP guidelines, regulatory agency and any other local authority requirements.• Responsible that the Trial Master Files are submission/inspection ready.• Lead the setup of the TMF Study Specific Document List (SSDL) • Monitor completeness and quality of TMF content for all assigned clinical trials until study close out. • Support documentation flow within projected timelines and determine course of actions to prevent and remediate delays and errors.Previous Employee History: Worked as a TMF Quality project manager for Customer platform studies in IQVIA, • Support set-up, maintenance and closure of TMF required activities in accordance with project specific defined TMF scope.• Lead and ensure occurrence of TMF KOM (internal/external)• TMF Quality Plan development and maintenance.• Ensure overarching Quality Management Process, e.g, TMF system set up/access process (platform specific, e.g, ELVIS, TMF HC, WS), training, source systems, etc.• Proactive review and analysis of TMF development, activation and ongoing metrics/KPIs through study closure.• Research, Analyze, Plan, Implement and employ proactive management, strong leadership techniques and people management skills to successfully develop research ideas, frame hypothesis, analyze and compile quantitative and qualitative data and synthesize findings.Drug safety analyst for 8 months(01/2013 - 09/2013) in Adichunchanagiri Institute of Medical Sciences providing online services for hospital medical doctors through Micromedix,CIMS,etc, Strong Knowledge in Pharmacological Principles in therapeutic areas like cardiovascular complications. Have done extensive review on Hypertension in my graduation since 2012 to 2013. Conducted free camp in collaboration with hospital by supplying free medicines, laboratory findings and continued three follow ups with the data.3

Experience

1. Senior Tmf Lead

   ICON plc

   Apr 2023 — Present

Education

• Sri Adichunchanagiri College of Pharmacy

  Doctor of Pharmacy (PharmD)

  2010 — 2013

• Little Buds High School

  Kottam Institute of Pharmacy, Pharmacy

  1993 — 2002

Skills

• Clinical Trials
• Clinical Pharmacy
• Clinical Data Management
• Clinical Research