Souhrn
About the Role
Major accountabilities:
- Contributes to all operational trial deliverables, according to timelines, budget, operational procedures, quality /compliance and performance standards.
- Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.
- 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.
- Adherence to Novartis policy and guidelines and external regulations
Minimum Requirements:
Work Experience:
- Financial Management.
- Project Management.
- Collaborating across boundaries.
- Operations Management and Execution.
Skills:
- Auditing.
- Clinical Monitoring.
- Clinical Research.
- Clinical Study Reports.
- Clinical Trial Management Systems.
- Clinical Trials.
- Data Auditing.
- Data Management.
- Health Sciences.
- Lifesciences.
- Project Management.
- Project Planning.
- Vendor Management.
Languages :
- English.
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