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Novartis

Lead Central Monitor

Posted 26 Days Ago
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Hybrid
Dublin, IRL
Senior level
Hybrid
Dublin, IRL
Senior level
Leads a team of Central Monitors and develops risk-based clinical trial monitoring strategies. Oversees trial-data surveillance, signal detection, risk reviews, and actionable insight generation. Partners with clinical, data, and risk teams to protect patient safety, data integrity, regulatory compliance, and trial quality. Guides protocol risk assessments, Key Risk Indicator and threshold design, issue resolution, audit readiness, and continuous improvement through analytics, technology, and Risk-Based Quality Management.
The summary above was generated by AI

Salary Range:

€63,600.00 - €118,000.00

Job Description Summary

Role Type: Hybrid Working, #LI-Hybrid
Primary Location: Barcelona, Spain
Other Locations: London, United Kingdom; Dublin, Ireland
Relocation Support: This role is based in Barcelona, Spain. Novartis is unable to offer relocation support: please only apply if accessible.
What if your leadership could transform how clinical trial risks are identified, understood, and managed across a global development portfolio? As Lead Central Monitor, you will lead and develop a team of Central Monitors while shaping monitoring strategies that protect patient safety, trial quality, and data integrity. Working across clinical, data, and risk-surveillance teams, you will turn complex information into actionable insights, strengthen risk-based monitoring practices, and help advance the Central Monitoring capability at Novartis.

Job Description

Key Responsibilities

  • Lead and develop a team of Central Monitors, building capability, engagement, and consistently high performance.
  • Shape central and site monitoring strategies tailored to program, study, and Development Unit risks.
  • Oversee trial-data surveillance, risk reviews, signal detection, and insight generation using Central Monitoring technology.
  • Translate complex risk signals into actionable insights that enable Clinical Trial Teams to investigate and resolve issues.
  • Partner with clinical, data, and risk-surveillance teams to implement effective monitoring and risk-mitigation approaches.
  • Guide protocol development, risk assessment, and the design of study-specific Key Risk Indicators and thresholds.
  • Ensure monitoring activities support clinical data integrity, regulatory compliance, audit readiness, and timely issue resolution.
  • Drive continuous improvement through analytics, technology, innovation, lessons learned, and Risk-Based Quality Management.

Essential Requirements

  • University degree in Life Sciences, Business, Operations, or a related discipline.
  • At least seven years of recent pharmaceutical or contract research organisation experience, including experience in clinical research.
  • At least five years of experience in central or site monitoring, clinical data analytics, data management, or a related discipline.
  • At least three years of recent people-management or team-leadership experience, with proven ability to develop high-performing teams.
  • Strong understanding of clinical trial development, study execution, protocols, study risks, and clinical trial risk-management processes.
  • Experience with centralised monitoring, Key Risk Indicators, Quality Tolerance Limits, and Risk-Based Quality Management approaches.
  • Strong knowledge of Good Clinical Practice, International Council for Harmonisation standards, and relevant health-authority requirements.
  • Strong analytical, digital, communication, and problem-solving skills, with the ability to interpret complex data and influence stakeholders in a global matrix environment.

Desirable Requirements

  • Advanced university degree.
  • Extensive knowledge of a relevant therapeutic area.
  • Experience using artificial intelligence, analytics, or other digital approaches to support transformation.
  • Manager-of-managers experience and a track record of developing diverse, high-performing teams.

 

Benefits & Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. 


Expected Annual Base Salary Range for role: €63,600 to €118,000   


The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.   


In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. 


The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. 


Read our brochure to learn more about our global total rewards offering:

Read our handbook (PDF 30 MB)

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.


Commitment to Diversity & Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.


Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. 


Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture


 

Skills Desired

Budget Management, Clinical Research, Clinical Study Reports, Clinical Trials, Collaboration, Data Analysis, Health Sciences, People Management, Regulatory Compliance

Novartis Dublin, Dublin, IRL Office

203 Merrion Rd, Dublin, Ireland, D04 NN12

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