Roles & Responsibilities:
• Lead end-to-end dose surveillance activities across multiple clinical trials from start-up to close-out.
• Perform routine and ad-hoc dose reviews, identify discrepancies, and coordinate follow-ups with sites and medical partners.
• Document dose-related operational risks in SPOT/COSMOS, ensuring inspection-ready records.
• Provide data-driven insights to trial teams, Clinical Monitoring Managers (CMMs), Medical Advisors, and functional stakeholders.
• Ensure audit and inspection readiness, adhering to ICH-GCP, SOPs, and regulatory expectations.
• Collaborate with Trial Managers on dosing and retention issues, strengthening relationships with site staff and internal partners.
• Coach site staff to improve dose compliance and documentation quality.
• Contribute to departmental training, knowledge sharing, and continuous improvement of surveillance methodologies.
• Support global cross-functional improvement projects and drive innovation in dose surveillance processes.
Qualification:
• Graduate degree in Life Sciences (M-Pharma, PharmD, BDS/MDS, Pharmacy, MSc Nursing) with strong understanding of clinical trial conduct and ICH-GCP.
Experience:
• Minimum 4 years in clinical trials within pharmaceutical, biotech, CRO, or hospital settings.
• Strong working knowledge of trial data, systems, and global clinical operations.
• Experience collaborating with diverse global stakeholders.
Skills:
• Excellent communication, relationship-building, and stakeholder management skills.
• Strong analytical mindset and familiarity with clinical IT systems.
• Ability to independently solve complex issues in evolving environments.
• High motivation, ownership, and continuous improvement mindset.
• Ability to coach, influence, and guide site and internal staff effectively.
About the Organisation:
Novo Nordisk is a global biopharmaceutical company dedicated to defeating serious chronic diseases and improving long-term health outcomes. The Centralized Monitoring Unit (CMU) in Bangalore leads Risk-Based Quality Management (RBQM), ensuring robust oversight of clinical trial data, early risk identification, and mitigation strategies. The organization fosters innovation, collaboration, and excellence in clinical development, while maintaining a patient-centric, inclusive, and purpose-driven culture.
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