Bharathi M Email & Phone Number

Bengaluru, Karnataka, India

• In charge of all the departments including OPD, Lab, Radiology, Cardiology, Cath -lab, Inpatient-wards, MICU, SICU, General-wards, ICU, Pantry, Marketing, Accounts managements, Finance etc.• Professional approach with an ability to work in multidisciplinary team.• Co-ordinate as Project leader Analyzing and reviewing the work flow process and Evaluating the performance with the intervals of time accordingly. Incorporation of project standards by distribution and allocation of workload. Ensuring the work conducted in accordance with Training Organizing meetings.

Bangalore

Bangalore

• Manage handling of projects including all tasks of Data cleaning, query generation, query tracking, database updates as per the DCFs, Database QC, compilation and maintenance of DM files and database lock activities including the quality control (QC) of the data.• To test data entry screens as well as programmed checks.• Creation and validation of edit checks.• Review data discrepancies within the clinical databases.• Assist in data coding and data review for quality.• To write, review, maintain and comment any DHP or any DM related documents if required.• Creation of DM SOPs/ work instructions.• Perform the activities of CRF designing and annotation.• CRFs tracking, data entry.• Medical coding, SAE reconciliation, attend review meetings to close outstanding clinical or statistical queries, work on close out activities for database lock, communicate with the team to provide final CSR report and all required documents.• Designed Oncology CRF’s using InDesign CS6 tool following Novartis Standards for more than 30 studies, Amendments for more than 40 studies. Maximum CRF pages reached more than 450.• Worked on updating PRO and Patient diary pages of different languages. With print order request.• Managed working on Amendments using Page Maker.• Managed working flexibly prioritizing work for in time deliverables when stringent timelines are noted due to time zone differences. • Take up calls or TC from home when required to escalate team queries.• Each and every study is a big challenge. Kept note on latest standard updates, version changes, Project and study specific Approvals.• Proved my best to satisfy client needs and received quite a lot of excellent motivational feedbacks with many appreciation mails from team.

Bangalore

• Over 6 years. 4 months of experience in a wide range of therapeutic areas of Data management, the activities include handling study including all activities of Protocol review, CRF designing, Data base testing, CRF’s tracking, Data entry, Data Validation, Medical coding, SAE reconciliation, QC of Study files, Creation of SOP’s and Work instructions, Guidelines and Documents creations, Training CRA’s, meetings via Teleconference, Project finance billing based on milestones and activities, attend kick off meetings, Proposal and Costing for data management services , Escalate issues- risk management through calls, chat, e-mail communications.• 1 Year of additional experience in Assisting Global resourcing team by Formatting CV’s into ClinTec format and uploads in the Database using FTP access, Co-ordinate with the candidates, Database updates for Feasibility Questionnaires. Work with regulatory documents, Literature study, Human guidelines for the regulatory assessment studies.

• Validate the study data of projects/studies assigned to with accuracy and high quality. Create and manage study data documents, provide relevant training when required and update versions and manage relevant documents. Design CRFs for studies and perform UAT/testing of database and create documentation for the same.• Co-ordinates with study team to ensure accurate and high quality of data is delivered within timelines.• Adjust work assignments or schedules for him and/or others in team to meet changing work priorities.• Ensure that the new recruits in Data Management group are adequately trained to perform the expected tasks.• Conduct the refresher training for new updates to data management best practices.• Monitor timelines and ensure that the deadlines are met on the project.• Attend project related meetings and inform supervisor on issues and ensure that the necessary tasks are completed.• Inform and co-ordinate with the supervisor on issues related to the progress, quality and resource on the projects.• Be proactive and responsive to internal/external customer needs.• Perform the activities that ensure the completeness and validity of clinical trial database, including protocol review and CRF designing and database testing.• Contribute in the review and evaluation of new techniques; participate in the development of database standards procedures.• Review of working practices and the further development if required and maintenance of standard operating procedures (SOPs) for Data Management.

• Manage handling of projects including all tasks of Data cleaning, query generation, query tracking, database updates as per the DCFs, Database QC, compilation and maintenance of DM files and database lock activities including the quality control (QC) of the data.• To test data entry screens as well as programmed checks.• Creation and validation of edit checks.• Review data discrepancies within the clinical databases.• Assist in data coding and data review for quality.• To write, review, maintain and comment any DHP or any DM related documents if required.• Creation of DM SOPs/ work instructions.• Perform the activities of CRF designing and annotation.• CRFs tracking, data entry.• Medical coding, SAE reconciliation, attend review meetings to close outstanding clinical or statistical queries, work on close out activities for database lock, communicate with the team to provide final CSR report and all required documents.• Designed Oncology CRF’s using InDesign CS6 tool following Novartis Standards for more than 30 studies, Amendments for more than 40 studies. Maximum CRF pages reached more than 450.• Worked on updating PRO and Patient diary pages of different languages. With print order request.• Managed working on Amendments using Page Maker.• Managed working flexibly prioritizing work for in time deliverables when stringent timelines are noted due to time zone differences. • Take up calls or TC from home when required to escalate team queries.• Each and every study is a big challenge. Kept note on latest standard updates, version changes, Project and study specific Approvals.• Proved my best to satisfy client needs and received quite a lot of excellent motivational feedbacks with many appreciation mails from team.

Bsc, Genetics, Microbiology, Biochemistry, A+

Activities and Societies: BscGave written exam

Post Graduation Diploma In Clinical Research, Clinical Research, A+

Activities and Societies: Clinical researchGave exam on clinical research

Bachelor'S Degree, Genetics, Microbiology, Biochemistry, 1St Class

Activities and Societies: Bsc