Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Clinical Scientific Expert I
Job Description
Summary
• Contributes, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team.
• Applicable to Clinical Scientific Expert IThe Clinical Scientific Expert I (CSE I) provides clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D in compliance with Novartis processes, ICH GCP and regulatory requirements. This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. The CSE I is a core member of the Clinical Trial Team (CTT) and may support program level activities as assigned.
Major accountabilities
• Implementing issue resolution plans; -Assist with program level activities (e.g., tracking of program -Managing interactions with relevant line functions including data management, drug supply management, clinical development and/or Novartis Country Pharma Organizations; -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators
• Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards.
• Proactive operational planning with effective contingency and risk mitigation plans.
• Applicable for Clincial Scientific Expert I: -Performing clinical data review and insights consistently and accurately which meets the Novartis quality standards, timelines, and is inspection ready.
• High quality contributions to study documents (e.g. protocol, ICF, clinical sections of CTA) -Clearly demonstrates Novartis Values and Behaviors (i.e. Innovation, Quality, Collaboration, Performance, Courage and Integrity.
Candidate Profile
Minimum Requirements
Work Experience :
• Cross Cultural Experience.
• Operations Management and Execution.
• Collaborating across boundaries.
• Project Management.
Skills :
• Clinical Research.
• Clinical Trial Protocol.
• Clinical Trials.
• Data Integrity.
• Learning Design.
• Life sciences.
• Risk Monitoring.
• Trends Analysis.
Additional Information
Job ID : REQ-10033700
Location : Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
Division : Development
Business Unit : Innovative Medicines
End Date : 10th January 2025
See All D.Pharm Alerts B.Pharm Alerts M.Pharm Alerts M.Sc Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email