NOVARTIS Clinical Scientific 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. Other responsibilities include:
1. Develop subject matter expertise (disease area
knowledge, clinical data review tools and/or processes).
2. Contribute
to Clinical Development and Analytics (CD&A) line function initiatives,
local and/or global education and process development projects, as required.
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