Novartis was created in 1996 through a merger of Ciba-Geigy and Sandoz. Novartis and its predecessor companies trace roots back more than 250 years, with a rich history of developing innovative products. From beginnings in the production of synthetic fabric dyes, the companies that eventually became Novartis branched out into producing chemicals and ultimately pharmaceuticals.
Job Title: Clinical Scientific Expert I
Job ID : 216422BR
Work Location : Hyderabad
Division : Global Drug Development
- The Clinical Scientific Expert I (CSE I) is responsible for ensuring high quality clinical trial data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle in compliance with Novartis processes, ICH GCP and regulatory requirements.
- This role applies the principles of clinical data review excellence with a focus on patient safety and data integrity.
- The CSE I is a core member of the Clinical Trial Team (CTT) and may support program level activities as assigned.
- Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Pharm D, PhD or MD preferable.
- Fluent English (oral and written) 1-2 years scientific, strategic and operational experience in planning, executing, reporting and publishing clinical studies in industry or Academia, or 3-4 years in Clinical Operations/Clinical Scientific role Intermediate knowledge of planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization or similar experience with an academic research institution.
- Good knowledge of Good Clinical Practice and drug development processes
- Strong scientific knowledge in at least one therapeutic area (e.g., understanding of basic mechanisms of diseases and associated symptoms, standard of care/treatment, scientific endpoints & clinical outcomes)
- Knowledge of principles of clinical data collection and reporting; ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting Analytical / computational background; ability to detect data trends and escalate as appropriate.