Novo Nordisk

Senior Central Monitor

Novo Nordisk  •  Bengaluru, IN (Onsite)  •  5 months ago
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Job Description

Department – Centralised Monitoring Unit (CMU)- Bangalore

Location: Bengaluru, India-Novo Nordisk Global Business Services (GBS), India

Department – Centralised Monitoring Unit (CMU)- Bangalore

Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment 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. Apply now and join a growing team, working in an international environment.

About the department

The Centralised Monitoring Unit (CMU)- Bangalore, is a department within the Global Trial Portfolio area. It is a perfect blend of skilled medical professionals (Medical reviewers) and technical programmers (Functional programmers) and 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.

The Position

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.

  • Lead the development and execution of centralised monitoring processes within a Risk-Based Quality Management (RBQM) framework, ensuring alignment with global standards and continuous improvement on assigned studies using vendor platform dashboards/outputs in accordance with NN SOPs, ICH/GCP, regulatory guidelines & directives.
  • Design and implement advanced operational monitoring strategies, leveraging data analytics, digital tools, and AI-powered solutions for enhanced risk detection and process optimisation.
  • 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. Prior experience with RBQM (Risk-Based Quality Management) and field monitoring as a CRA is desirable. Familiarity with analytical tools is preferred, as well as experience using SAS, Python, R, and SQL are desirable.
  • Drive process optimisation initiatives to improve efficiency, including strategies to enhance Clinical Research Associate (CRA) productivity and effectiveness.
  • Provide subject matter expertise on central monitoring methodologies, systems, and tools, mentor and train team members across operational, medical, and statistical domains.
  • Respond to monitoring findings, audits, and inspections, ensuring robust corrective actions and process enhancements.
  • Champion a culture of innovation, continuous improvement, and knowledge sharing across the CMU and broader organisation.
  • Represent the CMU in cross-functional and global initiatives, influencing the adoption of smart, digital, and AI-driven approaches.

Qualifications:

  • Minimum of bachelor’s degree in life science/scientific or health care discipline.
  • Above 5 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
  • Expert knowledge of Good Clinical Practice (GCP), with emphasis on ICH-GCP E6 R2 and R3 guidelines, and a proven RBQM mindset.
  • Experience in process optimisation and driving efficiency, particularly in supporting and enabling CRA teams. 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 work collaboratively and effectively in a cross functional and culturally diverse teams.
  • Strong technical skills, including data analytics, visualisation software, and digital tools. Basic understanding of AI tools and their application in clinical operations is highly desirable. 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. Experience working with Clue Points solutions will be an advantage.

Working at Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing.

Contact

To submit your application, please upload your CV online (click on Apply and follow the instructions).

Deadline

15-Jan-2026.

Disclaimer

It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process.

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

We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.

Novo Nordisk

About Novo Nordisk

We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic disease and create long-term health.

Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and work to treat, prevent, and even cure diseases that affect millions of lives. Founded in Denmark in 1923, today we employ more than 77,000 people in 80 offices around the world – all united by our bold purpose to drive change to defeat serious chronic diseases. Want to learn more? Visit www.novonordisk.com.

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Industry
Chemicals & Materials
Company Size
10,000+ employees
Headquarters
Bagsværd, DK
Year Founded
1923
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