GCP Compliance Manager - Clinical Programs & Trials

Novartis UK; Dublin; Hybrid; EUR 89,000 - 164,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

Parental leave 14 weeks

Job summary

Novartis in Dublin seeks a GCP Compliance Manager to guide clinical programs and trials, ensuring adherence to global standards and risk-based decision making. You will partner with study leaders, vendor managers, and QA to enable quality and inspection readiness across a diverse portfolio.

This role requires an advanced scientific degree and deep regulatory knowledge, with strong investigative and communication skills to translate complex requirements into actionable guidance.

Qualifications

• Advanced degree in science, engineering, or related discipline.
• Significant experience in clinical operations and clinical trial management.
• Strong knowledge of Good Clinical Practice standards and global regulatory requirements.
• Proven ability to investigate complex issues and perform root cause analysis.
• Excellent communication skills translating compliance concepts to practical guidance.
• Ability to work in cross-functional, matrixed teams and influence stakeholders.
• Ability to manage multiple trials independently and prioritise demands.

Responsibilities

• Provide compliance oversight for clinical programs and trials, ensuring adherence to GCP standards.
• Act as primary compliance partner to Clinical Trial Teams for complex regulatory scenarios.
• Lead cross-functional discussions and resolve quality issues using structured investigation and root cause analysis.
• Translate regulatory requirements into clear guidance for clinical stakeholders.
• Coordinate inspection readiness activities and CAPA management.
• Monitor indicators and trends to detect portfolio risks and support mitigation.
• Deliver self-assessment checks and controls, sharing insights for improvement.
• Collaborate with Quality Assurance and Development to ensure aligned practices.
• Support program and trial quality assessments for informed risk-based decisions.
• Champion a culture of quality, data integrity, and accountability across Global Clinical Operations.

Skills

GCP Compliance

Clinical Operations

Regulatory Knowledge

Cross-functional

Root Cause Analysis

Communication Skills

Education

Advanced degree in science/engineering

Job description

Summary

Location: Dublin, Ireland

Other Locations: London, United Kingdom.

Novartis is unable to offer relocation support: please only apply if accessible. Novartis is unable to sponsor Visas for this location

Step into a role where your expertise helps Clinical Trial Teams navigate some of their most complex and high-risk decisions. As a GCP Compliance Manager – Clinical Programs & Trials, you will operate as a trusted partner embedded within the clinical trial environment, working across a portfolio of studies to provide expert guidance on Good Clinical Practice and support teams staying in compliance. You will support teams in solving complex scenarios which require careful risk-assessment —translating technical requirements into clear, actionable insights that enable informed decision-making.

About The Role

Acting as a key point of contact across study leaders, vendor managers, and cross-functional stakeholders, you will enable issue resolution, strengthen inspection readiness, and ensure trials are delivered to the highest standards of quality and compliance. This is a role for a curious, solutions-oriented professional who thrives on investigation, collaboration, and influencing outcomes in a fast-paced, global clinical landscape.

Key Responsibilities

• - Provide compliance oversight for clinical programs and trials, ensuring adherence to Good Clinical Practice standards
• - Act as primary compliance partner to Clinical Trial Teams, enabling decision-making on complex regulatory scenarios
• - Lead cross-functional discussions and resolution of quality issuesusing structured investigation and root cause analysis
• - Translate complex regulatory requirements into clear, actionable guidance for cross-functional clinical stakeholders
• - Coordinate inspection readiness activities, including preparation and inspection management, in addition to subsequent CAPA management
• - Monitor key indicators and trends to portfolio issues detect early signals, and supportproactive mitigation strategies
• - Deliver self-assessment checks and controls, sharing insights to strengthen compliance and continuous improvement
• - Collaborate across functions, including Quality Assurance and Development, to ensure aligned and effective compliance practices
• - Support quality assessments of programs and trials and enable informed, risk-based decision-making
• - Champion a strong culture of quality, data integrity, and accountability across Global Clinical Operations and beyond

Essential Requirements

• - Advanced degree in science, engineering, or related discipline
• - Significant experience in clinical operations and clinical trial management within a pharmaceutical or healthcare environment
• - Strong knowledge of Good Clinical Practice standards and global regulatory requirements
• - Proven ability to investigate complex issues, perform root cause analysis, and develop effective corrective actions
• - Excellent communication skills with ability to translate technical compliance concepts into clear, practical guidance
• - Strong problem-solving mindset with curiosity and ability to navigate ambiguity and regulatory trade-offs
• - Demonstrated ability to work effectively in cross-functional, matrixed teams and influence diverse stakeholders
• - Ability to work independently, manage multiple trials simultaneously, and prioritise across competing demands

Desirable Requirements

• - Experience supporting audits and inspections, including preparation and interaction with health authority inspections
• - Openness to adopting and experimenting with artificial intelligence and new technologies to optimize ways of working

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: 75,880.00 - 140,920.00 GBP Annual

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.

We also offer a variety of competitive benefits in kind to help you thrive personally and professionally.

• insurance plans
• retirement plans
• wellbeing resources
• global recognition programs
• flexible and hybrid working options, where possible
• minimum 14 weeks paid parental leave

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Commitment to Diversity and Inclusion / EEO

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

Read our handbook (PDF 30 MB)