393433BR
Apr 23, 2024
Italy

Summary

-Monitors patient data and study-related information related to clinical study sites and clinical trial participation. Ensures the investigator adheres to research protocols, regulatory requirements and good clinical practices and provides input into data validation plan. Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits where applicable. May monitor study sites and audit facility selection.

About the Role

Major accountabilities:
  • 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)
Key performance indicators:
  • 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
Minimum Requirements:
Work Experience:
  • Operations Management and Execution.
  • Project Management.
  • Collaborating across boundaries.
  • Representing the organization.
Skills:
  • NA.
Languages :
  • English.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Development
Pharmaceuticals
Italy
Field Force (Italy)
Research & Development
Full time
Regular
No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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393433BR

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