Novartis
Pharmaceutical
GCPComplianceManager-ClinicalPrograms&Trials
Neural analysis suggests this role is
optimal for Manager candidates.
“GCP Compliance Manager - Clinical Programs & Trials at Novartis. Skills: GCP Compliance, Clinical Trials, Regulatory Requirements, Risk Management. Provide compliance oversight. Act as primary compliance partner”
Industry & Context.
Investigate complex issues; Root cause analysis; Develop corrective actions; Problem-solving mindset; Navigate ambiguity; Navigate regulatory trade-offs
12 days per month onsite, Subject to eligibility criteria for remote
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, Ability to investigate complex issues, Ability to perform root cause analysis, Ability to develop effective corrective actions, Ability to translate technical compliance concepts, Ability to work independently, Ability to manage multiple trials, Ability to prioritise across competing demands
Nice to Have
Experience supporting audits, Experience supporting inspections, Experience with health authority inspections, Openness to adopting AI, Openness to experimenting with new technologies
What You'll Do.
Provide compliance oversight
Act as primary compliance partner
Enable decision-making on complex scenarios
Lead cross-functional discussions
Lead resolution of quality issues
Perform structured investigation
Perform root cause analysis
Translate complex regulatory requirements
Coordinate inspection readiness activities
Manage subsequent CAPA
Monitor key indicators
Support proactive mitigation strategies
Deliver self-assessment checks
Share insights to strengthen compliance
Share insights for continuous improvement
Collaborate across functions
Ensure aligned compliance practices
Ensure effective compliance practices
Support quality assessments
Enable informed decision-making
Enable risk-based decision-making
Champion a culture of quality
Champion data integrity
Champion accountability
How You'll Work.
Team & Collaboration
Study leaders; Vendor managers; Cross-functional stakeholders; Quality Assurance; Development; Global Clinical Operations
Communication Scope
Translate technical concepts; Practical guidance
Full Job Description
**Job Description Summary** #LI-Hybrid For Hybrid working there is an expectation of 12 days per month onsite. This role can also be provided on a Remote working basis, subject to eligibility criteria. Eligibility for remote work can be discussed at interview stage. Location: Westworks, London, UK Other Locations: Dublin, Ireland. Please apply to the Dublin advertisement for this location This role is based in London, UK. 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 issues using structured investigation and root cause analys
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