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    Central Monitor

    Novo Nordisk
    3+ years
    Not Disclosed
    Bangalore
    10 Nov. 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    About Novo Nordisk

    Novo Nordisk is a global healthcare leader with over 100 years of experience in driving change to defeat chronic diseases, especially diabetes. Our focus is on improving the lives of millions of patients worldwide through innovation in biological medicines. As one of the 20 most valuable companies globally, we are committed to expanding our reach and improving health outcomes for more than 40 million people every day. At Novo Nordisk, life is at the heart of everything we do, and our employees are central to our mission of creating lasting change in healthcare.

    Department Overview: Centralised Monitoring Unit (CMU)

    The Centralised Monitoring Unit (CMU) in Bangalore is part of the Global Trial Portfolio and brings together a diverse team of professionals including medical reviewers, medical illustrators, functional programmers, statistical monitors, and central monitors. This multidisciplinary team focuses on risk-based medical monitoring, ensuring patient safety in clinical trials by identifying key operational risks and ensuring compliance with protocols. By utilizing cutting-edge technology and data visualization tools, the team monitors data patterns, detects anomalies, and cleans medical data, ensuring high standards of clinical trial integrity.

    Position: Central Monitor

    Location: Bangalore
    Department: Centralised Monitoring Unit (CMU)

    As a Central Monitor, you will play a critical role in monitoring operational risks and ensuring the safety of trial participants. Your responsibilities will include defining, tracking, and reviewing Key Risk Indicators (KRIs), providing insights on trial performance, and ensuring adherence to regulatory requirements. This role will require close collaboration with internal stakeholders, including trial teams, and ensuring timely communication of findings to enable effective decision-making.

    Key Responsibilities

    • Risk Monitoring & Compliance:

      • Define standard and trial-specific KRIs related to patient safety, data quality, and regulatory compliance.
      • Perform ongoing centralized operational monitoring of assigned studies using vendor platform dashboards.
      • Ensure operational reviews align with SOPs, ICH/GCP guidelines, and regulatory directives.

    • Data Analysis & Reporting:

      • Provide inputs to applications and systems used for monitoring operational data.
      • Report findings and communicate operational risks to relevant stakeholders to aid in decision-making.

    • Stakeholder Collaboration & Meetings:

      • Act as a primary contact for assigned studies and participate in project meetings.
      • Contribute to discussions and share best practices with CMU colleagues and external stakeholders.

    • Continuous Improvement & Learning:

      • Stay informed about global SOPs, GCP regulations, and other requirements to ensure compliance.
      • Contribute to the ongoing development of monitoring strategies and practices within the department.

    Qualifications

    • Education:
      • Minimum Bachelor’s degree in life sciences, scientific, or healthcare disciplines.
    • Experience:
      • At least 3 years of clinical research experience with a solid understanding of drug development and risk-based quality management.
      • Prior experience as a CRA or in field monitoring is desirable.
      • Familiarity with data visualization tools for aggregate data review is an advantage.
    • Skills & Competencies:
      • Strong understanding of clinical trial design and execution.
      • Excellent communication and presentation skills.
      • Proven ability to manage multiple projects and prioritize tasks effectively.
      • Ability to work independently, under tight deadlines, and in cross-functional teams.
      • Attention to detail, proactive problem-solving, and resilience to change.

    Working at Novo Nordisk

    At Novo Nordisk, we strive to foster a culture of inclusion and continuous development. Our employees play a crucial role in the advancement of global health. We work collaboratively toward transforming healthcare and creating innovative solutions for patients worldwide. By joining us, you’ll be part of an international team that is life-changing and deeply committed to improving global health.

    Application Process

    To apply, please submit your CV through our online application tool.

    Deadline: 28th November 2024

    Important Disclaimer

    Please be aware that fraudulent job offers may be circulating, posing as Novo Nordisk. Novo Nordisk never extends unsolicited job offers or asks for personal information or funds. If you receive any suspicious offers, please verify them through our official recruitment channels.

    Commitment to Diversity and Inclusion

    At Novo Nordisk, we value the unique perspectives of our employees and recognize that our success depends on a diverse workforce. We are committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities we impact. Together, we’re life-changing.

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