Novartis Clinical Scientifc Expert – I Master's, PharmD,
MPharm, 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)
1. 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.
2. 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.
3. In conjunction with the relevant line functions, may
contribute to Case Report Form (CRF) development, and support the
implementation of data capture tools.
4. 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.
5. May contribute (in collaboration with relevant line
functions) to the development of study-level documents, including clinical
sections of key regulatory documents, such as Investigator’s Brochures,
briefing books, safety updates and submission dossiers. In collaboration with
relevant line functions, review/write clinical trial documents for study CSR
activities, and publications.
6. May support pharmacovigilance activities (e.g.,
reviewing/contributing to aggregate reports/patient narratives, attendance of
Safety Monitoring Meetings (SMT)), if required.
7. Produce training materials and provide training to iCTT.
8. Support/present at study level meetings (Investigator
Meetings, Data Monitoring Committee (DMC) meetings or others), as required.
9. Develop subject matter expertise (disease area knowledge,
clinical data review tools and/or processes).
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