Data Manager

• Presently associated with Quintiles Research (India) Private limited, Bengaluru as “Associate Clinical Data Coordinator-2 in Oncology, Neuroscience and Cardiovascular therapeutic areas from 31/03/2014 to present.Key Responsibilities: Perform data management activities on the assigned project in a timely and efficient manner. Generate queries to clarify and improve the quality of the data. Test and execute validation procedures. Update database with query resolutions. Perform the database testing. Ensure that deliverables, timelines and quality targets for the study are met as per client expectations. Follow-up and get resolutions for issues from Client. Adherence to Quintiles and Client SOPs. Perform data administration activities like downloading & uploading data files using Medidata Rave, iMedidata, Inform and Clinbase. Frequent communication with Client via telecoms. Provide feedback to the clinical team on protocol and CRF. Provide ad-hoc data listings as and when needed. Prepare study documentation like validation procedure specifications, Level-1 corrections documents, CRF filling guidelines etc. for the assigned study.Other Responsibilities: Being part of Quintiles Non-Production account creation team I was involved in providing access to environment’s like MIG, PREMIG, UAT, DEV, TRAIN, TSDV and VAL for iMedidata database. Helping the iMedidata users in fixing the issues related to Non-Production environment. Coordinating with the Non-Production account creation team in tracking the information regarding number of projects to which access has been granted and number of users in the database.

• Associated with St Johns Research Institute, Bengaluru as “Clinical Research Associate” in Dept. of Cardiology from 05/08/2011 to 30/04/2012.Key responsibilities:  Assisting PI during subjects screening, randomization, and follow up visits.  Instructing and helping CRC’s in relation with trials. Calling IVRS for enrolment, randomization, and drug acknowledgment. Ensure CRC entering e-CRFs as per the source data & resolving the query generated by DM team.  Entering the subject visit details into data base like Medidata rave, Inform and Oracle clinica. Reporting SAE to EC & CRO/Sponsor promptly.  Coordinating with the Sponsor/CRO. Submitting Trial Status Report to EC on every six month.  Tracking lab reports. Maintaining archival of study related records.Clinical trial Delegated in as CRA (Indication Mentioned): Phase III - Prevention of major cardiovascular events in elderly people  Phase III - Class II chronic systolic heart failure  Phase III - Prevention of Systemic-thrombo-embolism (SEE) and stroke events in patients with history of atrial fibrillation.  Phase III - Prevention of thrombotic events in patients with history of MI  Phase III - Pulmonary arterial hypertension  Phase III-Prevention of recurrent cardiovascular events among stable post- Myocardial Infarction patients. Phase III - Secondary prevention of coronary events