Central Monitor (Karnataka)

Central Monitor (Karnataka)

30 Jul
|
Novo Nordisk
|
Karnataka

30 Jul

Novo Nordisk

Karnataka

Job Summary

Central Monitor

Location Bangalore, India

Does your motivation come from challenges and working in a dynamic environmentDo you thrive where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position for you. Apply now and join a growing team, working in an international environment.

Your new role

As Central Monitor, you will be responsible for providing inputs in defining standard and trial-specific key risk indicators and performing ongoing monitoring of operational risks. You will ensure that both standard and trial-specific Key Risk Indicators (KRIs) impacting patient safety, data quality and regulatory compliance are appropriately defined as per protocol and monitoring strategy prior to the start of centralised operational monitoring review.

Your day-to-day responsibilities will include:

- Performing ongoing centralised operational monitoring activities on assigned studies using vendor platform dashboards and outputs, in accordance with Novo Nordisk SOPs, ICH/GCP and regulatory guidelines and directives
- Utilising advanced data visualisation and analytics tools to proactively identify risks and drive data-driven decision-making
- Providing inputs to applications, databases and systems used to monitor operational data
- Communicating findings of operational review to relevant stakeholders to enable decision making, acting as the primary contact and participating in project meetings for assigned centralised monitoring studies
- Contributing to discussions and sharing learnings and best practices with wider CMU colleagues and other relevant stakeholders




- Maintaining knowledge of and acting in compliance with global and local SOPs, GCP and other regulatory requirements
- Championing continuous improvement and innovation, sharing best practices and driving change across the department

Your department

In Research Development, you'll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs.

The Centralised Monitoring Unit (CMU) Bangalore is a department within the Global Trial Portfolio area. It is a unique blend of skilled Medical Reviewers, technical Functional Programmers and Statistical Monitors. Medical Reviewers are actively involved in risk-based medical monitoring in collaboration with medical specialists in Denmark, ensuring patient safety and the wellbeing of clinical trial participants through protocol compliance and identification of clinically significant outliers. Functional Programmers develop operational visualisations in data visualisation tools to support trial teams on proactive centralised monitoring, while Statistical Monitors detect unusual data patterns, systematic errors and potential compliance issues or fraud across trials.

Your skills and qualifications





We are looking for a Central Monitor who brings analytical rigour, a quality mindset and a passion for continuous improvement. To succeed in this role, you'll bring with you:

- A minimum of a bachelor's degree in life science, a scientific or a healthcare discipline
- 3+ years of relevant clinical research experience with a valuable knowledge of the drug development process and risk-based quality management (RBQM) principles, including demonstrated experience applying RBQM principles in clinical trial operations
- In-depth knowledge of Good Clinical Practice (GCP) guidelines, with particular focus on ICH-GCP E6 R2 and R3, and a solid understanding of clinical trial design, execution and operations
- Skill in aggregate data review and interpretation using visualisation/analysis software, along with a basic understanding of AI tools and their application in clinical operations
- Robust communication and presentation skills, with the ability to interact proactively and professionally with colleagues, stakeholders and management across cross-functional, culturally diverse teams
- The ability to manage multiple projects and priorities independently under tight deadlines, with strong attention to detail, proactivity and resilience to change

Prior CRA/field monitoring experience and hands-on experience with CluePoints solutions will be considered an advantage.

Experience Level

Mid Level

Disclaimer : This job posting & Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Central Monitor (Karnataka)
🏢 Novo Nordisk
📍 Karnataka

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