Ravina Shekhawat

About Ravina Shekhawat

Overall professional experience of 12 years with strong background in clinical research industry managing phase I-IV pharmaceutical trials (Start-up projects, in-house monitoring, Risk based monitoring, medical data review, Site Report Review, Budget and finances, Quality review and compliance, Trainings, Team management, Vendor management, Good Clinical Practice (GCP), Mentorship.Able to handle operational challenges, reversing operational inefficiencies, implementing robust processes, and elevating the of compliance. Characterized as analytical, strong, concise and a hands-on leader possessing exceptional problem solving anddecision-making skills. Well-versed managing multiple sites, ensuring clinical data integrity and compliance with protocols andstandards. Team player with strong verbal and written communications skills. Able to work effectively with all levels of staff/teamand patients from diverse social, ethnic, and economic backgrounds with a strong passion for developing positive and lastingrelationships. Currently leading a team of 25+ associates across the globe.

Experience

1. Senior Centralized Monitoring Lead

   IQVIA

   May 2023 — Present · Mumbai, IN

   Act as functional lead for Risk Based Monitoring studies and provide oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines, and project COP from Applications/ Analytics/ Therapeutics/ Quality perspective.• Serve as a liaison between Project Manager/Project Lead and CRAs, CM, SRS, SLDR for study deliverables including site management, monitoring, ensuring compliance with monitoring plan, applicable SOPs and ICH/GCP guidelines.• Conduct periodic review of site level KRIs & historic site performance according to Central Monitoring Plan.• Early identification risk/issues occurring during study conduct and creating mitigation plan.• Facilitate efficient and effective review of Site Visit Reports and assure consistent standards of implementation for quality to meet or exceed quality standards. • Conducting CRA trainings and/or assisting them for on-site visits as needed for site selection, site initiation, site monitoring and site close out visits.• Ensure subject safety, data integrity, escalation of issues and timely and responsive feedback in compliance with standard operating procedures, Good Clinical Practice (ICH GCP) guidelines, protocol requirements and regulatory compliance. • Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested and note CMS specific action items.• Perform functional lead responsibilities by serving as primary point of contact for all clinical aspects of assigned project.• Developing and maintaining successful cross-functional relationship between various internal and external stakeholders.• Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials, Resource Management

Education

• Bharati Vidyapeeth

  Bachelor of Dental Surgery, Dentistry

  2009 — 2013