Currently working as Lead Data Manager overseeing multiple projects , handling study deliverables from study start-up to close-out. Liase with Data Managers and Programmers to drive the process. Proficient in Clinical Data Management activities across start-up, conduct and close out phase. Accountable for all DM activities, resource planning, provide EDC and study specific training to sites, team members, mentoring, eTMF documentation etc. Strong knowledge in all therapeutic areas. Expertise in Medidata Rave, Medrio, Inform, SPSS, Confero, Veeva platforms.Imednet, CRIO. Handled Automation project, RPA and Excel process automation.
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Sr Clinical Data ManagerVeranex Apr 2023 - PresentIndia -
Senior Clinical Data Coordinator Ii ( Study Team Lead)Veranex Nov 2020 - Mar 2023Etawah, Uttar Pradesh, India -
Senior Clinical Data Coordinator Ii ( Study Team Lead)Quartesian Nov 2020 - Jan 2022India -
Business Process Lead (Lead Clinical Data Manager)Tata Consultancy Services Aug 2019 - Nov 2020Mumbai Area, India -
Business Process Lead (Clinical Data Manager)Tata Consultancy Services May 2017 - Aug 2019Mumbai Area, India -
Clinical Data Coordinator (Medical Device Studies For, Emea,Us,Australia)Stryker Nov 2013 - Apr 2017Gurgaon, India• Participation in the preparation /collection of paper Case report forms (CRFs)• Coordinate with the study sub-team to understand the specific requirements of study Database designing and Edit checks in SPSS and Inform database.• Study Start Up activities like database designing, writing Data Validation Specification • User acceptance testing (UAT) of the new Database including the Electronic Data Capture (EDC) Systems to ensure screen design matches protocol/ Standard requirements, edits are programmed and operating as intended in Inform.• Log CRFs and X-rays into the clinical study database • Updating the EDC database and closing the queries in accordance with the clarified DCFs returned from site.• Ensure data collection is in accordance with the relevant GCP standards and other legal requirement ,Ensure an error free, quality data with no open queries • Edit check report, monthly reports, DCF tracking report ,Metrics, KPIs distribution and discussion with the clinical team• Statistics analysis of forms and provide analysis report to Clinical study team in SPSS. -
Project Coordinator Worked With Baxter India Pvt LtdHealth Impetus Pvt Ltd Apr 2012 - Nov 2013Gurgaon• Managing and supporting the Project Manager in Nurses daily duties.• Ensuring that relevant Data management information is captured and analyzed.• Handling Research Document ICF Base Line form, Patient Annexure and Drop Out form.• Data entry of Clinical Patient Data into Master Sheet.• Coordinate with Patient, Dietician, Nurses to ensure the Project Implement.• Identify, analyze, prioritize, mitigate End Stage Renal Disease Dialysis Patient Data and communicate project risks
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Patient Care ExecutiveSuper Religare Laboratories Ltd. Dec 2010 - Apr 2012GurgaonRole and Responsibilities 1. Handling all the queries of Patient and Customer 2. Take a Home Collection for all Mumbai Region and Delhi NCR 3. Check E-mail to resolve all the queries by mail 4. Resolve all queries related with medical term. 5. Give all information related with Test to the Patient 6. Give a Precaution and Pre condition for the entire test 7. Meeting with Doctors and Technicians for interpretation of reports -
Trainee Clinical Data ManagementFortis Clinical Research Ltd. Feb 2010 - May 2010Faridabad Area, IndiaPhase 1 Vaccination Trial and BA/BE Studies Roles and Responsibilities1. Data Entry with speed 30 w/pm2. CRF Tracking3. Comprehensive Data Review4. Quality Control And Discrepancy Management5. Query generation and updating6. Testing of Validation procedure and edit checks
Somesh Kumar Education Details
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Marketing And It -
Clinical Research Education And Management AcademyClinical Research And Data Management, Oracle Clinical 4.5.1, Basic Pharmacology -
Industrial Microbiology, Zoology, Chemistry, Punjab History And Culture,English -
High School
Frequently Asked Questions about Somesh Kumar
What company does Somesh Kumar work for?
Somesh Kumar works for Veranex
What is Somesh Kumar's role at the current company?
Somesh Kumar's current role is Sr Clinical data manager.
What schools did Somesh Kumar attend?
Somesh Kumar attended Institute Of Management Technology, Ghaziabad, Clinical Research Education And Management Academy, Guru Nanak Dev University, Kendriya Vidyalaya.
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