Summary
About the Role
- Experienced specialists performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of assigned clinical trials.
- Is responsible to deliver data within timelines and required quality standard,, responsible for adherence to monitoring procedures in accordance with GCP & ICH, local regulations and SOPs.
- Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial -Performs site Initiation Visit, ensures site personnel is fully trained on all trial related aspects -Applies company policies and procedures to resolve a variety of issues -Frequent internal company and external contacts.
- Represents organization on specific projects -Contributes to some cost center goals and objectives -Is the frontline liaison between Novartis and sites to ensure successful collaboration, site engagement and meeting Novartis expectation on milestone and deliveries -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
- Deliver customer satisfaction results for internal and external customers -Delivery of Clinical Trials to quality standards and agreed timelines -Adherence to Novartis policy and guidelines and external regulations
Work Experience:
- Operations Management and Execution.
- Project Management.
- Collaborating across boundaries.
- Representing the organization.
- NA.
- English.
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