Associate Central Monitoring Specialist
Company: Novo Nordisk Global Business Services (GBS)
Location: Bangalore, Karnataka, India
Department: Clinical Development
Employment Type: Full-Time
Application Deadline: 23 June 2026
About the Role
Novo Nordisk is seeking an experienced Associate Central Monitoring Specialist to join its Centralized Monitoring Unit (CMU) within Clinical Development. This role serves as a Subject Matter Expert (SME) in Risk-Based Quality Management (RBQM) and Central Monitoring, driving oversight, risk identification, data quality, compliance, and operational excellence across global clinical trials.
The ideal candidate will possess strong expertise in clinical trial operations, centralized monitoring, risk management, data analytics, regulatory compliance, and stakeholder collaboration while contributing to the continuous advancement of RBQM strategies and monitoring capabilities.
Key Responsibilities
Central Monitoring & RBQM Execution
Serve as a Subject Matter Expert (SME) for Central Monitoring and Risk-Based Quality Management (RBQM).
Perform centralized monitoring activities using dashboards, analytics platforms, and Novo Nordisk systems.
Define, monitor, and evaluate Key Risk Indicators (KRIs).
Support risk-based monitoring strategies across global clinical studies.
Ensure effective oversight of trial conduct, quality, and compliance.
Risk Management & Data Analytics
Analyze aggregate clinical trial data to identify risks, trends, anomalies, and compliance concerns.
Investigate and document identified issues and potential risks.
Escalate critical findings to relevant stakeholders.
Support root cause analysis and risk mitigation activities.
Drive proactive risk detection through data-driven insights.
Project Leadership & Operational Excellence
Lead or support complex monitoring projects and operational workstreams.
Apply project management principles to ensure timely and high-quality deliverables.
Manage competing priorities across multiple studies and initiatives.
Contribute to continuous process improvement activities.
Process Standardization & Documentation
Ensure consistency and standardization of centralized monitoring processes.
Develop and maintain SOPs, work instructions, guidance documents, and operational procedures.
Align documentation with Novo Nordisk Process Management Framework.
Support governance and process compliance initiatives.
Cross-Functional Collaboration
Collaborate closely with:
RBQM Specialists
Clinical Research Managers (CRMs)
Clinical Research Associates (CRAs)
Trial Managers
Data Managers
Functional Programmers
Business Analysts
Act as a key liaison between the Central Monitoring Unit, RBQM Office, and other stakeholders.
Facilitate effective communication across global teams.
Audit, Inspection & Compliance Management
Lead audit and inspection readiness activities for Central Monitoring.
Represent Central Monitoring processes during regulatory inspections and audits.
Support CAPA development, implementation, tracking, and closure.
Ensure adherence to GxP, ICH-GCP, and regulatory requirements.
Maintain a strong quality and compliance culture.
Training & Mentorship
Mentor and support junior team members.
Assist with onboarding, training programs, and capability development.
Promote knowledge sharing and best practices across teams.
Contribute to competency-building initiatives.
Innovation & Continuous Improvement
Identify opportunities for automation and process optimization.
Utilize analytics and technology solutions to improve efficiency.
Support the evolution of centralized monitoring methodologies and tools.
Contribute to innovation initiatives within Clinical Development.
About the Department
The Centralized Monitoring Unit (CMU) operates within Novo Nordisk's Clinical Drug Development organization and plays a critical role in ensuring data quality, patient safety, protocol compliance, and risk oversight across global clinical trials.
The team comprises:
Medical Reviewers
Medical Specialists
Functional Programmers
Statistical Monitors
Clinical Operations Experts
Together, they leverage advanced analytics, visualization tools, and RBQM methodologies to proactively identify risks and improve clinical trial execution.
Required Qualifications
Education
Bachelor's Degree in:
Life Sciences
Pharmacy
Biotechnology
Nursing
Medical Sciences
Healthcare or Related Scientific Discipline
Experience
Minimum 10+ years of experience in the pharmaceutical, biotechnology, CRO, or clinical research industry.
Significant experience in:
Clinical Trial Operations
Centralized Monitoring
Risk-Based Quality Management (RBQM)
Clinical Study Oversight
Risk-Based Monitoring Strategies
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Hamburg |Rhineland Palatinate :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Wavre |Tipperary :
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Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Montreal |Brussels :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Manila |Croatia :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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Be'Er Sheva | Netanya | Yavne | Kfar Saba | Tel Aviv |Remote :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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