Lead Central Monitor: Risk & Data Team Leader

Novartis UK; Barcelona; Hybrid; EUR 64,000 - 118,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible/hybrid working options

Parental leave (14 weeks)

Job summary

Novartis in Barcelona, Spain, seeks a Lead Central Monitor to lead a team of monitors and develop monitoring strategies across clinical programs. This role shapes risk-based monitoring practices to protect patient safety, data integrity, and trial quality while collaborating with clinical, data, and risk-surveillance teams globally.

The ideal candidate brings 7+ years in pharma/CRO, strong leadership experience, and deep knowledge of GCP/ICH standards.

Qualifications

• University degree in Life Sciences, Business, Operations, or related discipline.
• 7+ years of pharmaceutical or CRO experience including clinical research.
• 5+ years in central or site monitoring, clinical data analytics, data management, or related.
• 3+ years of people-management or team leadership experience.
• Strong understanding of clinical trial development, study execution, protocols, study risks, and risk-management processes.
• Experience with centralised monitoring, Key Risk Indicators, Quality Tolerance Limits, and Risk-Based Quality Management.
• Strong knowledge of GCP, ICH standards, and health-authority requirements.
• Strong analytical, digital, communication, and problem-solving skills.

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.

Skills

People management

Analytical thinking

Digital/computational skills

Effective communication

Education

University degree in Life Sciences / related discipline

Advanced degree preferred

Tools

Central Monitoring technology

Quality Management systems

Job description

Novartis in Barcelona, Spain, seeks a Lead Central Monitor to lead a team of monitors and develop monitoring strategies across clinical programs. This role shapes risk-based monitoring practices to protect patient safety, data integrity, and trial quality while collaborating with clinical, data, and risk-surveillance teams globally.

The ideal candidate brings 7+ years in pharma/CRO, strong leadership experience, and deep knowledge of GCP/ICH standards.