GCP Compliance Manager
Pharmaceutical
GCPComplianceManager-ClinicalPrograms&Trials
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“GCP Compliance Manager - Clinical Programs & Trials at GCP Compliance Manager. Skills: GCP Compliance, Clinical Trials, Risk Management. Provide compliance oversight. Ensure adherence to GCP standards”
Industry & Context.
Investigate complex issues; Root cause analysis; Problem-solving mindset; Navigate ambiguity
What They're Looking For.
Must Have
Advanced degree in science, Significant experience in clinical operations, Significant experience in clinical trial management, Knowledge of Good Clinical Practice standards, Knowledge of global regulatory requirements, Investigate complex issues, Perform root cause analysis, Develop effective corrective actions, Translate technical compliance concepts, Problem-solving mindset, Navigate ambiguity, Navigate regulatory trade-offs, Work effectively in cross-functional teams, Influence diverse stakeholders, Work independently, Manage multiple trials, Prioritize across competing demands
Nice to Have
Experience supporting audits, Experience supporting inspections, Preparation and interaction with health authority inspections, Openness to adopting AI, Openness to experimenting with new technologies
What You'll Do.
Provide compliance oversight
Ensure adherence to GCP standards
Act as primary compliance partner
Enable decision-making on complex scenarios
Lead cross-functional discussions
Resolve quality issues
Translate regulatory requirements
Coordinate inspection readiness activities
Monitor key indicators
Support proactive mitigation
Deliver self-assessment checks
Strengthen compliance
Support continuous improvement
Collaborate across functions
Ensure aligned practices
Ensure effective practices
Support quality assessments
Enable risk-based decision-making
Champion a culture of quality
Champion data integrity
Champion accountability
How You'll Work.
Team & Collaboration
Cross-functional stakeholders; Study leaders; Vendor managers; Quality Assurance; Development
Communication Scope
Translate technical concepts
Process & Methodology
Manage multiple trials
Full Job Description
**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 manag
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