GCP Compliance Manager - Clinical Programs & Trials

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