Life Sciences Clinical Scientific Expert Job at Novartis, Apply Online
Novartis is a global healthcare company dedicated to reimagining medicine for patients worldwide. With a mission to improve and extend people’s lives, Novartis is committed to developing innovative treatments across a wide range of disease areas.
Job Posting: Clinical Scientific Expert I
Job ID: 382209BR
Date: Dec 04, 2023
Location: India
About the Role
As a Clinical Scientific Expert, you will join Novartis’ Global Drug Development (GDD) team, which consists of 150 clinical scientific experts globally. In this role, you will be responsible for ensuring the highest quality clinical trial data and regulatory reports throughout the life cycle of each program, across all disease areas. You will provide clinical and scientific inputs at both the study and program level, contributing to Novartis’ mission of reimagining medicine for patients worldwide.
Role Responsibilities:
- Ensure high-quality clinical trial data review/insights and analysis as directed by the Integrated Clinical Trial Team (iCTT).
- Perform thorough clinical data review and identify clinical data insights through patient-level review and trend analysis.
- Support Interim Analysis, Database, and Post Lock activities.
- Collaborate with relevant line functions to enhance the quality of clinical data review/insights.
- Contribute to the development of the Data Review/Quality Plan (DRP/DQP) and data review strategy.
- Contribute to Case Report Form (CRF) development and support the implementation of data capture tools.
- Facilitate data review process improvements and implementation of innovative data analysis processes and tools.
- Contribute to the development of study-level documents, including clinical sections of key regulatory documents.
- Support pharmacovigilance activities, if required.
- Produce training materials and provide training to the Integrated Clinical Trial Team (iCTT).
Role Requirements:
- Advanced degree in life sciences/healthcare (or clinically relevant degree) is required.
- Master’s, PharmD, M.Pharma, PhD, MBBS, BDS, MD strongly preferable.
- Fluent in English (oral and written).
- At least 1 year of experience in the pharmaceutical industry/clinical research organization.
- Basic knowledge in planning, executing, reporting, and publishing global clinical studies.
- Experience in clinical operations is preferable.
- Strong interpersonal and negotiation skills.
- Ability to work under pressure and collaborate across boundaries for shared success.
- Knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process.
- Strong analytical/computational background.
- Demonstrates strong medical/scientific writing skills.
- Knowledge and application of statistical analysis methodology.
Business Unit: CLINICAL DEVELOPMENT & CMO GDD
Location: India
Site: Hyderabad, AP
Company / Legal Entity: Nov Hltcr Shared Services Ind
Functional Area: Research & Development
Job Type: Full Time
Employment Type: Regular
Shift Work: No
Diversity & Inclusion / EEO:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Keywords: life sciences, clinical, scientific expert, Novartis, healthcare, pharmaceutical industry, clinical research organization, clinical trial data, regulatory reports, patient safety, data integrity, statistical analysis, clinical trial design, global drug development. Life Sciences Clinical Scientific Expert Job at Novartis, Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
