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Senior Central Monitor

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1 Vacancy
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Job Location drjobs

Bengaluru - India

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

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) technical programmers (Functional programmers statistical monitors) and Medical Illustrators. 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. Medical Illustrators are responsible for developing engaging visual content for our clinical meetings.

The Position

As Senior 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 (KRIs) 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 . 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.
  • 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.

Qualifications:

  • Minimum of bachelors 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
  • Skill in aggregate data review and interpretation using visualization/analysis softwares
  • 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.
  • 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.

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 72000 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 were working toward something bigger than ourselves and its a collective effort. Join us! Together we go further. Together were life changing.

Contact

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

Deadline

29th July 2025.

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.

Were not your typical healthcare 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.


Required Experience:

Senior IC

Employment Type

Full Time

Company Industry

About Company

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