Hybrid Lead Central Monitor: Risk-Based Trial Oversight

Novartis

Sabadell

Hybrid

EUR 64,000 - 118,000

Full time

40 hours ago
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Benefits offered by this job

Flexible/Hybrid working
Parental leave 14 weeks
Insurance plans
Retirement plans
Wellbeing resources
Global recognition programs

Job summary

Novartis in Barcelona, Spain, is seeking a Lead Central Monitor to lead a team of Central Monitors and shape monitoring strategies across programs. Hybrid working with global collaboration across clinical, data, and risk-surveillance functions, ensuring patient safety and data integrity.

The role requires 7+ years in pharma/CRO and 5+ years in central or site monitoring, plus 3+ years of people management. Strong knowledge of GCP/ICH and RBQM is essential.

Qualifications

  • Seven years of pharmaceutical or CRO experience.
  • Five years in central or site monitoring, clinical data analytics, data management, or related.
  • Three years of people-management or team-leadership experience.
  • Strong knowledge of GCP, ICH standards, and health-authority requirements.
  • Experience with centralised monitoring, KRIs, QTLs, and RBQM approaches.
  • Strong analytical, digital, communication, and problem-solving skills.

Responsibilities

  • Lead and develop a team of Central Monitors.
  • Shape central and site monitoring strategies tailored to program risks.
  • Oversee trial-data surveillance, risk reviews, signal detection, and insight generation.
  • Translate complex risk signals into actionable insights for Clinical Trial Teams.
  • Partner with clinical, data, and risk-surveillance teams on monitoring and risk mitigation.
  • Guide protocol development, risk assessment, and design of KRIs and thresholds.
  • Ensure monitoring activities support data integrity, regulatory compliance, and audit readiness.
  • Drive continuous improvement through analytics, technology, and RBQM.

Skills

Analytical skills
Digital skills
Communication skills
Problem-solving
Stakeholder management
Team leadership
People-management
Quality management

Education

University degree in Life Sciences, Business, Operations, or related discipline
Advanced university degree

Job description

Novartis in Barcelona, Spain, is seeking a Lead Central Monitor to lead a team of Central Monitors and shape monitoring strategies across programs. Hybrid working with global collaboration across clinical, data, and risk-surveillance functions, ensuring patient safety and data integrity.

The role requires 7+ years in pharma/CRO and 5+ years in central or site monitoring, plus 3+ years of people management. Strong knowledge of GCP/ICH and RBQM is essential.

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