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About Company

Join a dedicated and passionate team of 150+ clinical scientific experts within the Global Drug Development (GDD) team at Novartis. Work to ensure the highest quality of clinical trial data and regulatory reports across all disease areas, supporting Novartis in reimagining medicine for patients worldwide.

Position Name :

Clinical Scientific Expert I

Organization :

Novatis

Qualification:

PharmD, M.Pharma, PhD, MBBS, BDS, MD , MSc

Experience:

1 to 2 Years

Salary:

25,000 - 35,000 /month

Location:

India

Major Accountabilities:

  • Ensure high-quality clinical trial data review, insights, and analysis as directed by the Integrated Clinical Trial Team (iCTT).
  • Perform clinical data review, identify clinical data insights through patient-level review and trend analysis, and support Interim Analysis, Database, and Post Lock activities.
  • Facilitate resolution of clinical data issues, collaborating with relevant line functions to enhance data review quality, emphasizing subject safety and eligibility, data integrity, trend identification, and analysis.
  • Contribute to the development of Data Review/Quality Plans (DRP/DQP) and data review strategies, ensuring consistent implementation of protocol-level deviations, eligibility criteria, study assessments, and other protocol aspects.
  • May contribute to Case Report Form (CRF) development and support data capture tool implementation.
  • Facilitate data review process improvements and identify delinquent/redundant reports and/or implement innovative data analysis processes and tools.
  • Contribute to the development of study-level documents, including clinical sections of key regulatory documents (Investigator’s Brochures, briefing books, safety updates, submission dossiers).
  • Review/write clinical trial documents for study CSR activities and publications in collaboration with relevant line functions.
  • Support pharmacovigilance activities, including reviewing/contributing to aggregate reports/patient narratives and attending Safety Monitoring Meetings (SMT), if required.
  • Produce training materials and provide training to iCTT.

Application Link