Senior Manager – Medical Data Review (Central Monitoring Unit)
Company: Novo Nordisk Global Business Services (GBS)
Location: Bangalore, Karnataka, India
Department: Clinical Development – Central Monitoring Unit (CMU)
Employment Type: Full-Time
Work Model: Hybrid (3 days per week from Bangalore office)
Experience Required: 8–12 Years (including 5+ years of management experience)
Salary Package
Expected CTC: ₹40 LPA – ₹70 LPA (Estimated market range based on senior leadership level, medical qualification, clinical development expertise, and pharmaceutical industry experience. Actual compensation may vary.)
Job Summary
The Senior Manager – Medical Data Review will lead medical monitoring activities within Novo Nordisk’s Central Monitoring Unit (CMU), ensuring high-quality clinical trial oversight, data integrity, patient safety, and regulatory compliance.
The role involves leading a team of medical reviewers, driving Risk-Based Quality Management (RBQM) initiatives, overseeing medical data surveillance, and collaborating with global clinical development teams to strengthen clinical trial quality and operational excellence.
Key Responsibilities
Medical Data Review & Clinical Trial Oversight
Lead and oversee medical monitoring activities for global clinical trials in alignment with:
Risk-Based Quality Management (RBQM) principles
ICH-GCP guidelines
Company SOPs and quality standards
Ensure effective medical data review strategies and execution across clinical development programs.
Monitor medical data consistency, laboratory data trends, and critical clinical trial parameters.
Support early identification of risks, data trends, and quality issues requiring corrective actions.
Ensure patient safety and data integrity through proactive clinical trial oversight.
People Leadership & Team Management
Lead, coach, and develop a team of medical reviewers and clinical data specialists.
Establish clear performance expectations, competency frameworks, and development plans.
Conduct performance reviews and support individual career development through Individual Development Plans (IDPs).
Build a high-performing team culture focused on quality, collaboration, and continuous improvement.
Manage team resources, workload allocation, and operational priorities across clinical programs.
RBQM Strategy & Process Improvement
Drive implementation and advancement of Risk-Based Quality Management practices.
Identify opportunities for process optimization and operational improvement.
Support strategic initiatives to enhance centralized monitoring capabilities.
Ensure CMU practices remain aligned with evolving clinical research methodologies and regulatory expectations.
Promote innovation through data-driven monitoring approaches.
Cross-Functional Collaboration
Represent Medical Monitoring and RBQM in cross-functional meetings, working groups, and steering committees.
Collaborate with:
Clinical Operations
Data Management
Biostatistics
Global Safety
R&D Quality
Trial Management teams
Partner with external stakeholders, including CROs, professional organizations, and regulatory authorities.
Support inspection and audit activities by ensuring continuous readiness.
Operational & Compliance Management
Manage line budgets and resource planning for medical data review activities.
Coordinate with peer Managers, Senior Managers, and Directors within RBQM and Central Monitoring functions.
Ensure compliance with Novo Nordisk policies related to:
Quality
Finance
Legal
Procurement
Human Resources
Maintain inspection readiness across assigned activities.
Required Qualifications
MD degree in Medicine, Science, or equivalent professional qualification.
Minimum 5+ years of management experience within the pharmaceutical or clinical research industry.
Extensive experience in clinical development and medical data review.
Strong understanding of:
Global drug development processes
Clinical trial lifecycle
GxP requirements
Risk-Based Monitoring (RBM) / Risk-Based Quality Management (RBQM)
Required Skills
Strong leadership and people management capabilities.
Experience managing diverse global teams.
Deep understanding of clinical trial oversight and medical monitoring.
Knowledge of regulatory expectations related to clinical data quality and risk management.
Ability to interpret clinical data and identify quality risks.
Strong stakeholder management and collaboration skills.
Excellent decision-making and problem-solving abilities.
Strategic thinking with a proactive and results-oriented mindset.
Ability to lead through organizational change and uncertainty.
Strong written and verbal communication skills in English.
Preferred Skills
Experience working within global pharmaceutical organizations.
Experience with centralized monitoring and medical review processes.
Knowledge of RBQM frameworks and clinical quality management systems.
Experience collaborating with CRO partners and regulatory authorities.
Experience supporting regulatory inspections and clinical trial audits.
Familiarity with data analytics, visualization tools, and AI-enabled clinical trial oversight solutions.
Career Opportunity at Novo Nordisk
Leadership role within a global Clinical Development organization.
Opportunity to shape the future of Risk-Based Quality Management.
Exposure to innovative clinical trial methodologies and global R&D programs.
Collaboration with international teams across India, Denmark, and other global locations.
Professional growth opportunities through leadership development and continuous learning.
Opportunity to contribute to safe and effective medicines reaching patients worldwide.
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) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Cork | Dublin | Limerick | Waterford |Ulster :
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Swords |Republic of China :
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China | Quarry Bay |Liaoning :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Witney |Ontario :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Auckland |New Zealand :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote - South America (Latin Americal) | Minnesota | Ireland | Tulsa | Remote - Europe | Springville | McFarland | Hungary | Zaragoza | French | Melbourne | Lousiana | Hammond | Slovakia | Manipal | Belgium | Leinster | Perth | Green Way | Remote - Africa | Riga | Nairobi | Castlebar | Blue Bell | Xzagreb | Faridabad | Milwaukee | Medan | Texas | Bountiful | Thailand | Remote - Middle East | Bishop | Victoria | Lenexa | Regulatory Labeling Manager (NA and LATAM Only) | Switzerland |Republic of Colombia :
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Jeddah | Riyadh | Rabigh | Khulais | Najran | King Abdullah Economic City |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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