Experience

• 

  Dr. reddy's laboratories

  Dec 2002 - Dec 2003

  Junior manager

  o Quality control analysis of marketed batches of various productso Regular calibration of various analytical instruments.o Handled quality control testing of stability batches

• 

  Dr. reddy's laboratories

  Jun 2006 - May 2011

  Clinical research associate

  o Handled clinical operation activities for multicentre phase III studies in India. o Assisted in the preparation of Protocol and CRF (Case Record Form).o Worked as a Clinical Research Associate handling the Site initiation process, Study Monitoring process and Study site close out process.o Study master file preparation and maintenance.o Assisted investigator in EC submission. o Regulatory submission of documents. o Assisted in Clinical trial report preparation.o Serious Adverse Event (SAE) reporting.o Clinical trial site management. Handled PMS studies of marketed products. Clinical overview of products. Show less

• 

  Iqvia india

  Jun 2011 - now

  Indication of studies worked: Alzheimer's Disease, Metastatic Cancer, Multiple Sclerosis Key Responsibilities: o Serve as Centralized monitoring-Subject Lead by participation in Project specific risk assessment meetings (Both Internal and Client), Development of study specific review plan, Setting up of review platforms, Assessment of work projections, Budget projection, Training and onboarding of team members, Target completion in relation to regular review and specific milestones, All other team specific lead activates till data base lock. o Serve as a Subject level Data reviewer (SLDR) and identify patient anomalies by performing Subject Level Data Review to ensure medical congruency/plausibility of a subject data per protocol. o With minimal guidance, provide project management expertise working with clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise o Maintain strong customer relationships o With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions o Ensure timely follow-up and resolution of compliance issues o Serve as Subject Matter Expert (SME) o Continuously look for opportunities to improve efficiency of tasks and quality of deliverables o Provide therapeutic area/indication training for the project clinical team. o Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. o May act as a Clinical Data Scientist for by reviewing the visualizations and identify potential issues of concern Show less o Serve as a Subject level Medical Data reviewer and identify patient anomalies by performing Subject Level Data Review to ensure medical congruency/plausibility of a subject data per protocol.o With minimal guidance, provide project management expertise working with clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertiseo Maintain strong customer relationshipso With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actionso Ensure timely follow-up and resolution of compliance issueso Served as Medical data Reviewer Point of contact for studieso Continuously look for opportunities to improve efficiency of tasks and quality of deliverableso Provide therapeutic area/indication training for the project clinical team.o Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.o Management of various process metrics at portfolio level.o Worked a subject matter expert in specific topics and was involved in training new joiners. Show less o Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.o Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areaso Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.o Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.o Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.o Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.o May provide training/assistance to more less experienced clinical staff. Show less

  • Senior Centralized monitoring Lead

    Sept 2017 - now

  • Assistant Medical Data Review Manager

    Feb 2013 - Sept 2017

  • Clinical Research Associate

    Jun 2011 - Jan 2013