Highlights:

Skills:

Senior Central Review Manager 01/2021 - current
Thermo Fisher Scientific, Hyderabad, Telangana India
Industry: Clinical Research Industry
Having 12 years of experience in Clinical Research with broad background in management of end-to- end clinical trials including of assisting in PLM, KOM, implementation of study protocols, system setup and management, monitoring of protocol, country and sites document management. Responsible for central continuous remote/ risk-based monitoring for global clinical trials Dedicated employee known for punctuality, pursuing employment options where good customer service and positive attitude
Manage a caseload of monitoring visit report reviews for assigned studies, ensuring compliance to the protocol, processes, timelines, applicable SOPs, and GCP guidelines • Review assigned visit reports in order to ensure all site issues are adequately documented, reported and followed up to resolution, as well as, assuring a high quality of SVRs • Assist CLs in the utilization of the standard annotations to limit unnecessary customization • Prepare and escalate issues noted in the site visit report which could impact subject safety, regulatory compliance and/or data integrity to the CLs and CRA LM and/or Clinical Site Monitoring Quality Manager as necessary. • Providing training to the new comers and work with other departmental related trackers also performing QC review--
Site Report Review Specialist 07/2017 - 01/2021
IQVIA RDS Pvt Limited, Bangaluru, Karnataka India
Industry: Clinical Research Organisation
Having 12 years of experience in Clinical Research with broad background in management of end-to- end clinical trials including of assisting in PLM, KOM, implementation of study protocols, system setup and management, monitoring of protocol, country and sites document management. Responsible for central continuous remote/ risk-based monitoring for global clinical trials Dedicated employee known for punctuality, pursuing employment options where good customer service and positive attitude
Responsible for review of Site Visit Reports for multiple clinical projects • Identify quality issues within study through regular review of clinical team communications including site communications • Collaborate with CL/CPM to define annotations, Site Visit Report (SVR) guidelines and study tools (monitoring flow sheets and trackers) to assure efficient completion of • Escalation of CRA report writing and SOP submission compliance issues to CL/CPM and Line Manager Attend regular teleconferences with CLs to discuss any SVR review issues illustrative of quality/performance deficiencies. Report Review Specialist/RSM--

Acharya Nagarjuna University 12/2005 - 04/2009
Guntur, Andhra Pradesh, India
Degree: Bachelor's Degree
Major:Bachelor of Pharmacy
Completed Bachelor of Pharmacy

Login to view resume: Vinay - Cv