Band

Level 3

Job Description Summary

-Monitors patient data & 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.

Job Description

Key Responsibilities:
•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

Essential Requirements:
•At least 1-2 years (for CRA level) working experience or equivalence
•Operations Management and Execution
•Project Management
•Representing the organization
•Collaborating across boundaries
•English

Skills Desired

Clinical Research, Clinical Study Reports, Clinical Trial Management Systems (CTMS), Clinical Trials, Clinical Trials Monitoring, Communication, Data Integrity, Decision Making, Life Science