Job Posting: Clinical Scientific Expert I at Novartis
Company: Novartis
Position Name: Clinical Scientific Expert I
Location: India
Salary: ₹25,000 – ₹35,000 / month
Qualifications: PharmD, M.Pharma, PhD, MBBS, BDS, MD, MSc
Experience: 1 to 2 years
About the 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.
Major Accountabilities:
Responsibility | Description |
---|---|
Data Review & Analysis | Ensure high-quality clinical trial data review, insights, and analysis as directed by the Integrated Clinical Trial Team (iCTT). |
Clinical Data Insights | Perform clinical data review, identify insights through patient-level review and trend analysis, support Interim Analysis, Database, and Post Lock activities. |
Issue Resolution | Facilitate resolution of clinical data issues, collaborating with relevant line functions to enhance data review quality, emphasizing subject safety, data integrity, trend identification, and analysis. |
Development of Review Plans | Contribute to Data Review/Quality Plans (DRP/DQP) and strategies, ensuring consistent implementation of protocol-level deviations, eligibility criteria, study assessments, and other protocol aspects. |
CRF Development | May contribute to Case Report Form (CRF) development and support data capture tool implementation. |
Process Improvements | Facilitate data review process improvements and identify redundant reports or implement innovative data analysis processes and tools. |
Document Development | Contribute to study-level documents, including clinical sections of key regulatory documents (Investigator’s Brochures, briefing books, safety updates, submission dossiers). |
Clinical Trial Documentation | Review/write clinical trial documents for study CSR activities and publications in collaboration with relevant line functions. |
Pharmacovigilance Support | Support pharmacovigilance activities, including reviewing/contributing to aggregate reports/patient narratives and attending Safety Monitoring Meetings (SMT), if required. |
Training & Development | Produce training materials and provide training to iCTT. |
Meta Description
Join Novartis as a Clinical Scientific Expert I in India, ensuring high-quality clinical trial data. Salary: ₹25-35K/month.