Kiran Vedula

Experience

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  Tata Consultancy Services

  Sept 2010 - Oct 2014

  Clinical Data Manager

  •Discrepancy management of the allocated countries on a daily basis.•Generation of summary reports (includes tracking of missing visits, missing QOL questionnaires, outstanding discrepancies and Lab related issues) for outstanding issues and discussing the same in the country calls.•Attending country calls and discussing issues on a monthly basis.•Processing of Signed CRFs/ QOL questionnaires and escalation of the issues and archival of the same.•Providing the intellectual inputs from the data management perspective to the client/sites in the understanding and resolution of infrequent or typical issues.•Pulling reports from Hyperion on an ongoing basis.•Sending discrepancy reports on weekly basis.•Archival activity and Handling Brios.•Communicating with monitors and SDM to ensure proper query resolution and timelines on an ongoing basis.•Data cleaning activities at the time of Locking.•Experience of UAT (User Acceptance Test).•Developed Data Management Plans and Data Validation Plans.•Participate in study kickoffs and provide DM input on CRF design as per protocol specifications.•Review of draft and final versions of pCRF and eCRF as per blood log, assessment schedule and protocol specifications.•Design of help text for study specific CRF as per the investigator and site requirements.•Creation of the Validation specification document with inputs from clinical team members such as Clinical trial leader and clinical programmer.•Conducted trainings on data management specific applications and practices for new joinees and interns. Show less

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  Cognizant Technological Solutions

  Nov 2014 - now

  Clinical Data Manager

  •Responsible for discrepancy management of assigned countries on a daily basis•Working as Trial Data Manager for assigned studies in OC-RDC•Creating summary reports such as tracking the missed out visits, QOL questionnaires, discrepancies and lab issues by following up on the outstanding issues•Answering the country calls and discuss the issues on a monthly basis•Processing of signed CRFs/ QOL questionnaires and escalation of the issues and archiving them•Extracting reports from Hyperion on ongoing basis and submitting weekly discrepancy reports•Coordinating with monitors and SDM in order to provide accurate query resolution•Managing archival activity and data cleaning activities at the time of locking•Performing SAE, AE, CM, MH and lab data reconciliation•Managing protocol-defined tests into the Rave Lab Tables for 2,000+ local laboratories•Responsible for clinical data review, query generation/resolution and data reconciliation to support the delivery of clinical data in accordance with data management plans•Managing clinical trials through review, computerization, cleaning and auditing of clinical data and databases in compliance with standard operating procedures•Identifying the errors and incomplete data in Oracle Clinical and OC-RDC•Validating clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines•Implementing strategy for data cleaning, design and programming of clinical databases•Maintaining laboratory information and laboratory reference ranges in rave•Reviewing and approving design, data review ground rules and database design according to Standard Operating procedures and protocol•Performing reconciliation of the clinical and safety databases and third party vendor data such as central laboratory, local labs, IVRS and ECG•Developing database and editing check specifications•Facilitating aspects of database release, maintenance and lock Show less