Job Summary

Associate Central Monitoring Specialist

Are you ready to bring your expertise in Risk-Based Quality Management to a team that's reshaping how clinical trials are monitored? Do you want to use data, analytics and your sharp eye for risk to help ensure the safety of patients in trials around the world? If so, read on and apply today for a career where your work has real impact.

Your new role

As an Associate Central Monitoring Specialist, you'll be a Subject Matter Expert within our Centralized Monitoring Unit (CMU), driving the operational execution of central monitoring activities across global clinical studies. You'll combine analytical insight, process expertise and stakeholder leadership to ensure data quality, risk oversight and consistent delivery within the RBQM framework.

Your key responsibilities will include:

- Acting as SME for Central Monitoring and RBQM, performing centralised monitoring activities through dashboards, analytics tools and Novo Nordisk systems, and supporting the definition and tracking of Key Risk Indicators (KRIs)
- Leading or supporting complex monitoring projects and workstreams, applying structured project management principles to ensure timely delivery of high-quality outputs
- Identifying, investigating, escalating and documenting operational risks and issues, and supporting root cause analysis and risk mitigation actions
- Ensuring standardisation of central monitoring processes and deliverables, taking content responsibility for SOPs, work instructions and guidance documents in alignment with the Novo Nordisk Process Management framework
- Collaborating closely with RBQM Specialists, CRMs, CRAs, Trial Managers, Data Managers, Functional Programmers and Business Analysts, and acting as a key interface between CMU,



RBQM Office and cross-functional stakeholders
- Mentoring and guiding less experienced team members, contributing to onboarding, training materials and a robust culture of knowledge sharing
- Owning audit and inspection readiness for Central Monitoring leading preparation, representing CM processes during audits and inspections, and driving timely CAPA development, implementation and closure
- Identifying opportunities to improve efficiency through automation, analytics and innovative approaches, contributing to the continuous evolution of the Central Monitoring function

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 Centralized Monitoring Unit (CMU) in Bangalore is part of our Clinical Drug Development area a unique blend of skilled medical professionals and technical experts. Medical Reviewers partner with Medical Specialists in Denmark to safeguard patient safety and protocol compliance, Functional Programmers build operational visualizations that enable proactive centralized monitoring, and Statistical Monitors uncover unusual data patterns, systematic errors and potential compliance issues. Join a dynamic,



collaborative team where your work directly shapes the integrity and outcomes of our clinical trials.

Your skills qualifications

We're looking for an experienced professional who thrives on solving complex challenges, brings deep RBQM expertise and enjoys influencing across cultures and functions. To succeed in this role, you'll bring:

- A minimum of a bachelor's degree in life science, a scientific or healthcare discipline
- 10+ years of experience in the pharmaceutical industry, with strong experience in clinical trial operations and Central Monitoring/RBQM, including application in study oversight and monitoring strategies
- Proven expertise in aggregate data analysis, risk identification and interpretation of complex datasets using visualisation and analytical tools, alongside a solid understanding of clinical trial design and end-to-end operational processes
- Demonstrated ability to lead complex projects independently, mentor colleagues, and influence stakeholders across functions in a global setting; experience in process standardisation, optimisation, audit readiness, inspections, CAPA management and regulatory interactions
- Strong working knowledge of GxP, ICH-GCP and regulatory expectations within clinical development, paired with excellent communication and influencing skills, sharp analytical thinking, a high quality and compliance mindset, and the ability to thrive in ambiguity and tight timelines

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.

📌 Associate Central Monitoring Specialist (Bengaluru)
🏢 Novo Nordisk
📍 Bengaluru