GCP Compliance Manager - Clinical Programs & Trials

Descripción del puesto:

Job Description Summary#LI-Hybrid

Location: Dublin, Ireland

Other Locations: London, United Kingdom. Please apply to the London advertisement for this location.

This role is based in Dublin, Ireland. 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.

Job Description
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
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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

Skills Desired