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Nisha S.

Sr. Director, Clinical Data Management

San Jose

18+ years of work experience

InClin, Inc
Sep 20214 yrs 10 mosPresent

InClin, Inc
Aug 20183 yrs 2 mosSep 2021

San Mateo

InClin, Inc
Mar 20171 yr 5 mosJul 2018

San Mateo

Threshold Pharmaceuticals
Jan 20151 yr 1 moJan 2016

Cognizant Technology Solutions
Jul 20112 yrs 8 mosFeb 2014

Santa Clara

Cognizant Technology Solutions
Jun 20091 yr 8 mosJan 2011

Working as a Project Lead in US and ensuring customer satisfaction in their Clinical Data Management Department through quality, on-time deliverables.
Cognizant Technology Solutions
Jun 20054 yrsMay 2009

Managed the project and led the delivery of end to end data management activities from setting up a study to the study lock, while ensuring timely deliverables. Tasks included protocol review, CRF designing, review of data standards, Edit checks specification, User Acceptance testing, Database set-up, Investigator and monitor instructions, conducting trainings, query management and preparing for database release.

Education

International Technological University (ITU)

Master of Business Administration (M.B.A.), Bio Management

International Technological University (ITU)

20142 yrs2016
University of Mumbai

MSc, Life Sciences (Biotechnology)

University of Mumbai

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Nisha S. on Tal

Headline

Sr. Director, Clinical Data Management

About

Nisha is a CCDM certified Data Manager with over 16 years in the Clinical Research Industry. She has gained valuable experience in all aspects of Data Management from study set-up till the study closure on multiple databases like Oracle Clinical, Rave, InForm. She specializes in Team Leadership, Project Management and coordination of Complex trial operations across distributed teams in multiple therapeutic areas in both EDC and paper environment. Specialties: Applications, Oracle Clinical, Rave, InForm, Medrio, Clinical Data management, Project Management, Leadership, Quality, Delivery, Training and People Management

Location

San Jose

Work experience

Sr. Director, Clinical Data Management at InClin, Inc, Sep 2021 - Present · 4 yrs 10 mos

Director, Clinical Data Management at InClin, Inc, Aug 2018 - Sep 2021 · 3 yrs 2 mos, San Mateo

Manager at InClin, Inc, Mar 2017 - Jul 2018 · 1 yr 5 mos, San Mateo

Sr. Clinical Data Manager at Threshold Pharmaceuticals, Jan 2015 - Jan 2016 · 1 yr 1 mo

Senior Associate/Data Management for Abbott Vascular at Cognizant Technology Solutions, Jul 2011 - Feb 2014 · 2 yrs 8 mos, Santa Clara

Onsite Lead Data Manager at Cognizant Technology Solutions, Jun 2009 - Jan 2011 · 1 yr 8 mos, Working as a Project Lead in US and ensuring customer satisfaction in their Clinical Data Management Department through quality, on-time deliverables.

Team Lead/Lead Data Manager for Pfizer project at Cognizant Technology Solutions, Jun 2005 - May 2009 · 4 yrs, Managed the project and led the delivery of end to end data management activities from setting up a study to the study lock, while ensuring timely deliverables. Tasks included protocol review, CRF designing, review of data standards, Edit checks specification, User Acceptance testing, Database set-up, Investigator and monitor instructions, conducting trainings, query management and preparing for database release.

Education

Master of Business Administration (M.B.A.), Bio Management, International Technological University (ITU)

MSc, Life Sciences (Biotechnology), University of Mumbai

Nisha S. - Sr. Director, Clinical Data Management in San Jose | Tal