Shilkumar Nagalgave
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Shilkumar Nagalgave
Consultant / Trainer
- 4 Jahre und 1 Monat, Juli 2011 - Juli 2015
Technical Analyst
Parexel International Pvt. Ltd.
Review of protocol, creating SOV, EDC Study Design Requirement. Coordinate with Programmers on IVRS setup, Study setup configurations, Database setup as per Study Design Requirement. Coordinate with Testers on Test Scripts and testing. Creation of Data Transfer Mapping Specification and coordinating with SAS programmers, Performing Functional QC of the DATASETS.
- 2 Jahre und 4 Monate, Apr. 2009 - Juli 2011
Clinical Data Manager
Unithink Soft Solutions India Pvt Ltd.
Review of protocol, creating SOV, Design Definition Document. Study setup configurations, Unique eCRFs design, edit checks, randomization setup, roles access, translations, subject diary, labs configuration. Coordinate with QC on study databases on Design. Review for mapping and data exports, as per CDISC standards. Acting as point of Contact.
- 11 Monate, Juni 2008 - Apr. 2009
CDA
Icon Clinical Research Private Ltd
Clinical Data Associate
- 1 Jahr und 5 Monate, Feb. 2007 - Juni 2008
Clinical Data Coordinator
Quartesian Clinical Research Private Ltd
Protocol review, Designing p-CRF from the Protocol, incorporating comments from Client Review. Annotating CRF’s using CDISC standards or Sponsor Standards, writing Edits per the final p- CRF.Work with the Programmer to develop, test and validate all project specific programming (i.e.. Edit Check Programs, UAT reports, database status reports, and any ad hoc programming requests). Coordinate Data Management activities of study databases with Data Manager.
Ausbildung von Shilkumar Nagalgave
- 2006 - 2007
Clinical Data Management
INSTITUTE OF CLINICAL RESEARCH
Clinical Data Management
- 2000 - 2003
Biotechnology
SWAMI RAMANAND TEERTH MARATHWADA UNIVERSITY
Biotechnology
- 1996 - 1999
Biology
SHIVAJI MAHAVIDYALAYA
Botany, Zoology, Chemistry
Sprachen
Englisch
Fließend
Hindi
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Sanskrit
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