Central Monitor

Novo Nordisk; Bengaluru; Vor Ort; INR 1.200.000 - 1.600.000; Vollzeit

Zusammenfassung

Novo Nordisk in Bangalore, India, is seeking a Central Monitor to define standard and study-specific KRIs and monitor operational risks. You will ensure KRI definitions align with protocol and monitoring strategy before CMU reviews.

The role involves centralised monitoring, data analytics, and collaboration with cross-functional teams to ensure patient safety, data quality and regulatory compliance while driving continuous improvement within the CMU.

Qualifikationen

• Bachelor's degree in life science or healthcare (or related field)
• 3+ years of clinical research experience with RBQM
• In-depth knowledge of GCP guidelines (ICH-GCP E6 R2/R3) and trial design
• Experience with aggregate data review using visualization/analysis software and basic AI tools
• Strong communication and presentation skills
• Ability to manage multiple projects and priorities independently

Aufgaben

• Perform centralised operational monitoring on assigned studies using vendor dashboards and Novo SOPs
• Use data visualization to identify risks and support data-driven decisions
• Contribute inputs to applications, databases and systems monitoring operational data
• Communicate findings to stakeholders and participate in project meetings for CMU studies
• Share learnings and best practices with CMU colleagues and stakeholders
• Maintain compliance with SOPs, GCP and regulatory requirements
• Champion continuous improvement and drive change in the department

Kenntnisse

RBQM principles

GCP guidelines

Data visualization

AI tools in clinical ops

Communication & presentation

Project management

Cross-functional collaboration

CluePoints experience

Ausbildung

Bachelor's degree in life science or healthcare

Tools

CluePoints

Jobbeschreibung

Company - Novo, Global Business Services

Department - Centralised Monitoring Unit

Location - Bangalore, India

Does your motivation come from challenges and working in a dynamic environment? Do you thrive where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you.

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 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 new 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 & 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 good 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
• Strong 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.

Working at Novo

At Novo, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and more than 371 million people worldwide need us. For over a century, we have stayed true to our mission of defeating serious chronic diseases - and we're reaching more patients than ever before. Here, you'll work alongside dedicated colleagues who share a genuine curiosity, explore bold innovations that advance health outcomes, and see the tangible impact of your contribution every day. Working here is not just a way to make a living, but a way to make a difference.

What We Offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

Deadline

26 October 2026. Applications are reviewed on an ongoing basis,

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.