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    Central Monitoring Head

    Novartis
    6-10 years
    Not Disclosed
    Basel Switzerland
    10 Feb. 10, 2025
    Job Description
    Job Type: Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

    Job Title: Central Monitoring Head

    Location: Basel, Switzerland (Hybrid); Dublin, Ireland; London, UK; East Hanover, New Jersey, USA; Hyderabad, India
    Job ID: REQ-10037985
    Date Posted: Jan 31, 2025
    Division: Development
    Business Unit: Innovative Medicines
    Functional Area: Research & Development
    Employment Type: Full-time, Regular

    Job Summary:

    Novartis is seeking a Central Monitoring Head to lead and oversee the establishment and execution of a state-of-the-art Central Monitoring (CM) function. The role is strategic, visionary, and focused on driving innovation and improving clinical trial monitoring processes. This position requires a leader capable of navigating change, building teams, optimizing monitoring performance, and collaborating with global stakeholders. The role also emphasizes driving cultural and operational change, ensuring alignment with trial monitoring workflows and industry regulations.

    Key Responsibilities:

    Strategy & Execution:

    • Establish and Implement Clinical Monitoring:

      • Develop and implement the Clinical Monitoring function, including processes, tools, and governance frameworks.
      • Define and execute strategies that leverage data analytics and centralized oversight to enhance clinical trial monitoring.
      • Optimize CM resourcing strategies, including recruitment, training, and team development.

    • Performance Monitoring & Reporting:

      • Establish key metrics/KPIs aligned with GCO priorities and industry benchmarks.
      • Regularly update senior leadership on monitoring performance, challenges, and improvement opportunities.
      • Ensure compliance with the latest regulations while evolving the CM function.

    Collaboration with Stakeholders:

    • Cross-functional Collaboration:
      • Act as the key link between CM, the global Risk Surveillance team, and field monitoring functions.
      • Coordinate interactions with internal teams such as data analysts, quality assurance, and regulatory affairs to ensure smooth clinical trial operations.
      • Integrate central monitoring into existing monitoring ecosystems by partnering with SSO Hub Heads.

    Leadership and Change Management:

    • Guiding Transformation:
      • Lead the transition to the CM model, driving organizational and cultural change.
      • Champion CM innovation by identifying opportunities for improvement and staying ahead of industry trends.
      • Foster collaboration across the organization by breaking down silos and ensuring alignment towards common goals.

    Key Performance Indicators:

    • Successful Build-up and Integration:
      • Establish a CM function and technology platform integrated with trial workflows.
      • Achieve high-quality monitoring deliverables, including compliance with data quality standards and issue resolution.
      • Consistently meet monitoring milestones within defined timelines and risk-based monitoring KPIs.

    Experience & Qualifications:

    • Education:

      • University degree in life sciences, business, or operations. Advanced degree preferred.

    • Experience:

      • At least 10 years of experience in the pharmaceutical industry, including significant experience in clinical research, clinical trial development, and risk management.
      • At least 6 years of experience in people management, with proven leadership skills in a global setting.
      • Experience in central monitoring or monitoring-related roles is preferred.
      • Strong expertise in GCP/ICH, health authority standards, and Novartis guidelines.

    • Skills:

      • Strong leadership, organizational awareness, and ability to work in a global, cross-functional matrix environment.
      • Expertise in study operations and process optimization.
      • Excellent technical, analytical, and problem-solving skills.
      • Ability to drive change, build high-performing teams, and articulate complex strategies

        Location Options:

      • Basel (City), Switzerland
      • Dublin (NOCC), Ireland
      • East Hanover, New Jersey, USA
      • Hyderabad, India
      • London (The Westworks), United Kingdom

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    Warsaw |

    Remote :

    Bishop | Thailand | Faridabad | Remote - Europe | Belgium | Ireland | Manipal | Nairobi | Medan | Lousiana | Slovakia | Bountiful | Remote - Africa | Remote - South America (Latin Americal) | Remote, USA | Springville | Hammond | Texas | Hungary | Remote | Xzagreb | Castlebar | Remote - Middle East | Blue Bell | Green Way | French | Leinster | Minnesota | Melbourne | Victoria | Tulsa | Switzerland | McFarland | Riga | Zaragoza | Lenexa |

    Bucharest :

    Bucharest |

    Makkah :

    King Abdullah Economic City | Jeddah | Riyadh | Najran | Rabigh | Khulais |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Peru | Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |