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 Research Associate
• 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 and ICH, local regulations and SOPs.
Major Accountabilities :
• 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.
• 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
• 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
• Operations Management and Execution Project Management Cross Cultural Experience
• Bachelor’s degree in any specialization. (Desirable) – Bachelor’s in Pharma/ Life Science.
• Minimum 1 to 2 years of relevant experience as CRA.
• Fluent in both written and Spoken English.
Experience : 1 to 2 years
Qualification : Bachelor’s in Pharma/ Life Science
Location : Hyderabad, AP
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Research & Development
End Date : 20th December, 2021
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