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$50 USD / hour
Flag of INDIA
hyderabad, india
$50 USD / hour
It's currently 6:20 PM here
Joined October 29, 2013
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Shilkumar N.

@shilkumarln

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$50 USD / hour
Flag of INDIA
hyderabad, india
$50 USD / hour
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Certified Clinical Data Manager / CONSULTANT

Professional in clinical data management and data strategy development helping to transform the current model into a more efficient and flexible model, highly focused on delivering value, using data to drive insights and innovation. Ultimately benefiting the sponsor, investigator and most importantly the patient. Data management professional with 9 years of experience in all aspects of clinical data management from study start up to post database lock spanning Phases 2 through 4. Proven record of managing multiple global trials and projects, including CRF designing, Data transfer mapping, and Study Closeout.

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Portfolio

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Experience

Technical Analyst / Clinical Programer II

Parexel International (India) Pvt. Ltd.
Jul 2010 - Present
Designation : Technical Analyst / Clinical Programer II Duration : (Jul 2010 – Present ) Reporting : Data Operation Lead Roles and Responsibilities: ● Review of protocol, creating SOV, EDC Study Design Requirement. ● Coordinate with Programmers on Study setup configurations, Database setup as per Study Design Requirement.. ● Coordinate with Testers on Test Scripts. ● Creation of Data Transfer Mapping Specification and coordinating with SAS programmers, ● Performing Functional QC of the DATASETS.

Clinical Data Manager

Unithink Soft Solutions India Pvt Ltd
Apr 2009 - Jul 2011 (2 years, 3 months)
Organization: Unithink Soft Solutions India Pvt Ltd. Designation : Clinical Data Manager Duration : (Feb 2011 – Jul 2011 ) Reporting : Project Manager Roles and Responsibilities: ● Review of protocol, creating SOV, Design Defination 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.\

Education

M.Sc-Biotechnology

Swami Ramanand Teerth Marathwada University, India 2001 - 2003
(2 years)

B.Sc

Swami Ramanand Teerth Marathwada University, India 1999 - 2001
(2 years)

Qualifications

Certified Clinical Data Manager

Society of Clinical Data Management
2013
Certified Clinical Data Manager from Society of Clinical Data Management

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