Dhaval Varma

WORK HISTORY

EDUCATION

SKILLS

ABOUT DHAVAL VARMA

Experienced in working for Global Contract Research Organization (CRO) as well as with Sponsor Company. As a part of the previous job roles was involved in the support and training of Global CRAs (including for Canadian and US research sites) on writing and finalization of Site Visit Reports. Also involved in finalization and implementation of the Corrective Action and Preventive Action (CAPA) plan. Involved in Quality Assurance. Have experience as Team Lead and as CRA. Have experience in handling Sponsor, Site & In-house Audits and Regulatory Inspections. Have been involved in introducing and training clinical trial sites on ICH-GCP, US FDA - 21 CFR, Regulatory requirements, Good Documentation Practices and Good Clinical Practices. Have experience in Sponsor communication, Project Cost, budgets & Finance, Stakeholder Management and Project Risk Management (Risk Mitigation), Resource Utilization, Project Dashboard analysis, Project Procurement, Vendor selection and Management. Have experience in all aspects of onsite Clinical Monitoring (Close to 6 yrs). Site Qualification or Selection visit (SQV or SSV), Site Initiation Visit (SIV), Site Monitoring Visit (SMV) and Site Close-out Visit (SCV). Experience in arranging On-site visits as per the monitoring plan, start-up activities, handling logistics, creation of & adherence to Site (Patient) Recruitment Action Plan, completeness and maintenance of TMF, Regulatory Communication, SDV, drug accountability, monitoring patient onsite safety and timely handling Protocol Deviations and violations. Reporting of Safety and SUSARs to Regulatory, Ethics and Other sites. Mentoring, training and onboarding local CRAs. Well versed with MS Office software. Experience of Working with Centralized Electronic Database (EDC) such as Inform, RDC. Clinical management software such CTMS, PeopleSoft and eTMF, IXRS, IWRS and IVRS. Experience in organizing events such as Principal Investigator’s Meeting.