Job ID 216416BR
Position
Title Clinical Scientific Expert I
Division Global Drug Development
Business
Unit Global Develop NPH
Country India
Work
Location Hyderabad
Company/Legal
Entity Novartis
Healthcare Shared Services, India
Functional
Area Research & Development
Job Type Full Time
Employment
Type Regular
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.
Minimum requirements
ü Advanced degree in life sciences/healthcare (or
clinically relevant degree) is required.
ü Pharm D, PhD or MD preferable.
ü Fluent English (oral and written)
ü 1-2 years scientific, strategic and operational
experience in planning, executing, reporting and publishing clinical studies in
industry/Academia, or
ü 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
ü Good knowledge of Good Clinical Practice and drug
development processes
ü 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)
ü 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
ü Analytical/computational background; ability to detect
data trends and escalate as appropriate
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