Novartis Drug Development Job – Clinical Scientific Expert Vacancy
Novartis Drug Development Job – Clinical Scientific Expert Vacancy. Life Science candidates apply online for a Clinical Scientific Expert – I position that is available at Novartis. Novartis is hiring msc/phd candidates, as per the details below in their Research & Development area:
Job Title: Clinical Scientific Expert – I
Job ID: 304091BR
Location: Hyderabad, AP
Division: Global Drug Development
Business Unit: CD&A GDD
Employment Type: Full-time
Your responsibilities include, however, are not limited to:
- Responsibility for ensuring high-quality clinical trial data review/insights and analysis as advised by the Integrated Clinical Trial Team (iCTT).
- Perform high-quality clinical data review and identify clinical data insights via patient-level review and trends analysis, supporting Interim Analysis, Database and Post Lock activities and assist in the resolution of clinical data issues.
- Work together with pertinent line functions to improve 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.
- Chips in to the development the Data Review/Quality Plan (DRP/DQP) and data review strategy, making sure 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 supply to Case Report Form (CRF) development, and support the implementation of data capture tools.
- Chip in to and facilitate data review process improvements e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis procedures and tools.
- Might supply (in collaboration with relevant line functions) to the development of study-level documents, consisting of 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.
- Might support pharmacovigilance activities (e.g., reviewing/chipping in to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)), if required. Produce training materials and provide training to iCTT.
- Sophisticated degree in life sciences/healthcare (or clinically relevant degree) is needed. PhD, MBBS, BDS, MD strongly preferable. Proficient English (oral and written).
- > 1-year experience in Pharmaceutical industry/ clinical research organization. Basic knowledge in planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization.
- Work experience in clinical operations preferable. Strong social skills – Capacity to work under pressure. Good negotiation and conflict resolution skills. Collaborates across boundaries for shared success.
- Resolve issues with minimal direction and understands when to raise. Fundamental knowledge of Good Clinical Practice, clinical trial style, statistics, regulatory processes, and clinical development process.
- Strong analytical/ computational background. Demonstrates strong Medical/ scientific writing abilities. Demonstrates knowledge and application of statistical analysis methodology and can identify trends and analyze/ interpret/ report data optimally.
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