Novartis was cr
eated 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
Job Description:
- 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.
Qualifications:
- 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.