Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Central Monitor
About the department
The Centralised Monitoring Unit (CMU)- Bangalore, is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). Medical reviewers actively involved in Risk based medical monitoring in collaboration with the medical specialists from Denmark, with focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that requires medical attention and medical data cleaning. The Functional Programmers develop operational visualisations in data visualization tools to support the trial teams on proactive centralised monitoring and Statistical Monitors perform detection of unusual data patterns, systematic errors and potential lack of compliance or fraud across trials.
As Central Monitor, an ideal candidate will be responsible for providing inputs in defining standard and trial specific key risk indicators and performing ongoing monitoring of operational risks. Ensure both standard and trial specific Key Risk Indicators (KRI’s) impacting patient safety and data quality and regulatory compliance are appropriately defined as per protocol, monitoring strategy etc prior to start of centralised operational monitoring review.
• Responsible to Perform ongoing centralised operational monitoring activities on assigned studies using vendor platform dashboards/outputs in accordance with NN SOPs, ICH/GCP, regulatory guidelines & directives.
• Provide inputs to applications, databases and systems used to monitor operational data.
• Responsible for communication and findings of operational review to relevant stakeholders to enable decision making. Act as primary contact for relevant stakeholders and participate in project meetings for assigned centralized monitoring studies .
• Contribute to discussions around share learnings and practices with wider CMU department colleagues and with other relevant stakeholders
• Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements.
• Minimum of bachelor’s degree in life science/scientific or health care discipline.
• Above 3 years of relevant clinical research experience with good knowledge of drug development process and risk-based quality management principles.
• Prior CRA/Field Monitoring and analytical tool experience is desirable
• Skill in aggregate data review and interpretation using visualization/analysis software’s
• Solid understanding of clinical trial design, trial execution and operations.
• Ability to successfully manage multiple projects and priorities.
• Good Communication & Presentation skills.
• Ability to plan well and handle complex tasks simultaneously and independently.
• Ability to work collaboratively and effectively in a cross functional and culturally diverse teams.
• Ability to work independently/responsively and with tight deadlines and under pressure.
• Quality mind-set and strong analytical skills, Strong attention to detail , Proactive and resilient to changes .
• Interact with colleagues, stakeholders, project members, management in a proactive and professional manner.
Qualification : Bachelor’s degree in life science / scientific
Experience : Above 3 years
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Centralised Monitoring Unit (CMU)
End Date : 20th Aug 2023
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