Verified recordBiotechnology Research

Senthil Balusamy

Associate Eclinical Solutions Director at Exelixis

Based in Pleasanton, United States

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Seniority

Other

Department

Other

Location

Pleasanton

Industry

Biotechnology Research

Company size

1.6K

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Email

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s•••••••@exelixis.com

Phone

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Background

About Senthil Balusamy

Ø An experienced professional with more than 16 years of experience in the field of IT Services, BPO, Pharma and CRO, with specialization in Clinical Data Management and Clinical Programming.Ø Expert in training and setting-up the Clinical Database Programming and Operation Support.Ø Proficient in exhibiting flawless operational activities which involve Project management and planning, risk management, resource management and handling project teamsØ Rave Subject Matter Expert (SME) in Rave Study Build, Integration setup using various tools & technologies (Example: IxR / IRT -> Rave, Rave ->DrugSafety, CTMS Rave, Lab -> Rave, TMS Rave), Migrations, tSDV, Custom Functions, Medidata Coder, Data Extractions, Rave Data Model and Custom Reports (Business Objects, Crystal Reports, J-Review and Cognos)Ø As a Medidata certified trainer have trained 300+ associates in Rave SDBE and trained 100+ associates in Rave Custom Functions and other Rave components.Ø Involved in Study Start-up, Conduct and Close-out activities for multiple Therapeutic areasØ Handled multiple projects effectively, even while working in fast-paced and stringent timelinesØ Travelled to Sweden, Japan, Germany and Poland to work closely with clients, coordinated effectively with offshore team in managing day to day operational activities.Ø Strong operation support experience in IT Service management (Incident, Problem and change management within the agreed SLA)Ø Highly instrumental in launching long-lasting delivery platform which provided strong quality of service with consistently predictable outcomesØ Have supported in the development of Global and Therapeutic Standard Libraries for eCRFs and Validation.

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