PromotedCurrently leading a multifunctional team through clinical studies activities that meet ICH/GCP and SOP/SOW requirements.• To ensure the effective interface between Clinical Laboratory Sciences and Clinical Study Team as a POC, especially the Study Delivery Lead/Global study Managers etc., by providing input in study protocol, laboratory Manual/Synopsis/instructions for investigator sites, informing about testing due dates, sample management or testing issues for a project or protocol for multiple clients.• Coordinating with the client with respect to their requirement for updating the list of site staffs and the Labcorp database so that the whole department is well-informed about the changes. Also to Provide input in the development of study protocol and related documents and establish the operational feasibility of each new study protocol. Escalate detected feasibility issues at both Clinical Study Team and Clinical Read-Out Team levels.• Working between Clients/Sponsor and other internal departments like Kit Inventory/IP tracking team and production team for the Kit supply/re-supply to the sites• Act as Subject Matter Expert for one or several processes of the team. Ensure standard processes and ways of working are in place across all projects and studies for all key activities of GSMs/RSCs, e.g., bio specimen custodian, Sample disposal, data revision, Resending lab reports, shipments of sample, study set-up with central laboratory, BRF process, blinding & reconciliation strategy, etc.• Provide frequent study/team updates to leadership upon requested requirements i.e., Team Metrics (Productivity, Utilization, Turn around Time, Quality and Training compliance (Weekly/Monthly Basis).•Responsible for ensuring development and implementation of applicable study plans (i.e., CMP, Communication/Risk Mitigation Plan), protocols/amendments, informed consent templates, eCRF & CRF forms/ICF completion guidelines and site reference manuals/instructions.

Clinical Process Associate-2QuintilesMay 2015 - Jun 20161 yr 2 moBangalore Resource Request. User list maintained. Alerts management. Follow-up for confirmation letter. Sites number allocation. Follow-up with TMF Lead for TMF setup. Set up EISF. CTMS, ELVIS, SP, access granting. SIV and IMV annotations, confirmation letter, Checklist and agenda. Monitoring plan, SDV plan, Study reference manual. ISF and Pharmacy Binders forms and templates. CRA News letters. Follow-up with Principal Investigators. Resource allocation for SIV’s. Resource allocation for SIV’s. Follow-up with Resource Manager for CRA allocation and also for system update. CRAs training compliance. Follow up SIV scheduling with CRAs. Checking the status of Lab Kits, IMP at sites. Preparing Binders and ISF. eTraining Compliance check for the new team members Follow-up with CRA Action Items resolution and Site Visit Follow Up letters to send to sites on time. Attend all Internal & External meeting in the month Updating Sponsor eCTMS tracker with site contact details to generate site numbers. Preparing Annotations for SIV, Newsletters. Updating Share point. Allocating sites numbers to all new sites.