Novartis Clinical
Scientific Expert-I Master's, PharmD, M.Pharma, PhD, MBBS, BDS, MD
Responsibility for ensuring high quality clinical trial data
review/insights and analysis as directed by the Integrated Clinical Trial Team
(iCTT)
• Perform high quality clinical data review and identify
clinical data insights through patient level review and trends analysis,
supporting Interim Analysis, Database and Post Lock activities and facilitate
resolution of clinical data issues. Collaborate with relevant line functions to
enhance the quality of clinical data review/insights with an emphasis on
subject safety and eligibility, data integrity, trend identification, analysis
and remediation, and identification of cases for medical review.
• Contributes to the development the Data Review/Quality Plan
(DRP/DQP) and data review strategy, ensuring that protocol-level deviations,
eligibility criteria, study assessments & other aspects of the protocol are
implemented consistently across the study.
• In conjunction with the relevant line functions, may
contribute to Case Report Form (CRF) development, and support the
implementation of data capture tools.
• Contribute to and facilitate data review process
improvements e.g. identification of delinquent/redundant reports and/or
implementation of innovative data analysis processes and tools.
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