PHARMAFull-time
Senior Manager - Medical Data Review
By Admin · Clinical Data Management
BANGALORE (IN)HYBRIDPOSTED: 9/4/2026
PHARMAFull-time
HIRING ORGANIZATIONNOVO NORDISKPharmaceuticals / Healthcare
ROLE DEFINITION & RESPONSIBILITIES
Role Overview
Lead the CMU-BLR Medical Data Review function and a team of medical reviewers supporting global clinical-trial oversight.
Plan and oversee the medical-monitoring aspects of clinical trials while ensuring data integrity, patient safety, regulatory compliance, and quality-by-design principles.
Drive Risk-Based Quality Management (RBQM) and medical data quality activities across clinical-development programs.
Medical Monitoring & Data Quality
Drive and oversee clinical-trial medical-monitoring planning and execution in accordance with RBQM principles, GCP requirements, and SOPs.
Ensure medical-data consistency and laboratory-data surveillance.
Support proactive identification of critical data, processes, and risks through centralized monitoring.
Enable timely corrective action and continuous improvement in clinical-data oversight.
People Leadership
Lead, coach, and develop a team of medical-review professionals.
Set clear competency and behavioural expectations for team members.
Conduct performance reviews and use Individual Development Plans (IDPs) to support employee growth.
Build, develop, and inspire diverse teams while maintaining strong people-leadership standards.
Resource & Financial Management
Manage line budgets and allocate resources across clinical trials and projects.
Coordinate with peer Managers, Senior Managers, and Directors across the RBQM and Centralised Monitoring area.
Cross-Functional & External Stakeholder Management
Represent RBQM and Medical Monitoring in cross-functional forums, working groups, and steering committees.
Collaborate with Medical & Science, Clinical Operations, Data Management, Global Safety, Biostatistics, Trial Management, RBQM, and R&D Quality teams.
Build relationships with external CROs, professional associations, and regulatory authorities, including during inspections.
Strategy, Quality & Compliance
Drive strategic initiatives and continuous-improvement activities.
Identify process enhancements and maintain the organisation's leadership in RBQM practices.
Ensure continuous audit and inspection readiness.
Maintain compliance with local GBS HR, Finance, Legal, Procurement, and Quality policies.
Department & Working Model
Part of Novo Nordisk Research & Development and the Centralised Monitoring Unit in Bangalore.
CMU Bangalore works closely with the RBQM office in Denmark and global trial teams.
The unit includes medical reviewers, central monitors, statistical monitors, and functional programmers working across monitoring strategies.
Hybrid working model with three days per week in the Bangalore office.
Qualifications
MD degree in science or similar qualification, supported by equivalent professional experience.
Minimum 5+ years of management experience within the pharmaceutical industry.
Strong people-leadership experience and ability to develop diverse teams.
In-depth understanding of the global drug-development value chain.
Strong knowledge of GxP requirements and external regulatory expectations for risk-based monitoring of clinical data.
Proven ability to collaborate across functions, cultures, and organisational levels, including with CROs and regulatory authorities.
Proactive, action-oriented, result-focused mindset with flexibility and cross-cultural awareness.
Ability to lead through uncertainty and organisational change.
Excellent communication, interpersonal, and decision-making skills.
Fluency in written and spoken English.
Company & Employee Environment
Novo Nordisk highlights opportunities for learning and development within a global healthcare organisation.
Benefits are designed to support employees across career and life stages.
The company promotes inclusion, equality of opportunity, diverse perspectives, shared purpose, and long-term healthcare impact.
REQUIRED VERIFIED SKILLS
Medical Data Review
Medical Monitoring
Clinical Development
Risk-Based Quality Management
RBQM
Risk-Based Monitoring
GCP
GxP
Clinical Data Quality
Laboratory Data Surveillance
Pharmaceutical Industry
Drug Development
Regulatory Compliance
People Leadership
Team Management
Resource Allocation
Budget Management
Audit Readiness
Inspection Readiness
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
The supplied Novo Nordisk job description does not disclose a specific salary range, bonus target, or numerical compensation figure. It states that Novo Nordisk provides benefits designed around employees' career and life stages and emphasizes learning and development opportunities within a global healthcare company. Candidates should therefore treat salary as undisclosed and assess the complete package, including fixed compensation, performance-related components where applicable, benefits, retirement provisions, and other employee offerings.
ORGANIZATION CONTEXT & CULTURE
Novo Nordisk is a global healthcare company with more than 100 years of innovation and leadership in diabetes care. The company is a world leader in diabetes treatment, as well as obesity, rare blood and endocrine disorders. Its core activities involve the discovery, development, manufacturing, and marketing of pharmaceutical products.
TEAM SIZE: 64,000+ employees
INDUSTRY: Pharmaceuticals / Healthcare
EXPECTED CAREER ROADMAP
This Senior Manager position provides a leadership pathway within clinical development, medical monitoring, centralized monitoring, RBQM, clinical data quality, and broader R&D operations. The role offers exposure to global trial teams, strategic RBQM initiatives, regulatory inspections, CRO relationships, resource and budget management, and senior cross-functional stakeholders. Strong performance can support progression toward Director-level clinical development, RBQM, medical monitoring, centralized monitoring, or broader R&D operational leadership roles.
APPLICATION ADVISORY
This role is not suitable for freshers or candidates with only 0–2 years of experience. Highlight an MD or equivalent relevant scientific qualification and at least 5 years of pharmaceutical management experience. Emphasize people leadership, team development, performance management, RBQM, risk-based monitoring, GCP/GxP, clinical-data quality, medical monitoring, laboratory surveillance, audit and inspection readiness, and regulatory expectations. Demonstrate experience working across Clinical Operations, Data Management, Global Safety, Biostatistics, R&D Quality, and CROs. Include measurable examples of managing budgets/resources, leading strategic initiatives, improving processes, handling regulatory inspections, and leading teams through change. Prepare for leadership and scenario-based interview questions involving risk-based monitoring, patient safety, data integrity, stakeholder conflicts, resource allocation, regulatory compliance, and team development.
RECOMMENDED TRAINING
1/5
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