Clinical Compliance Manager

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Clinical Compliance Manager in Italy.

This role is a key position within clinical development, focused on ensuring the highest standards of quality and regulatory compliance across clinical trials. You will act as a trusted advisor to study teams, providing expert guidance on Good Clinical Practice (GCP), regulatory requirements, and internal procedures. The position involves close collaboration with cross-functional stakeholders to identify, assess, and mitigate compliance risks throughout the clinical lifecycle. You will play a critical role in maintaining inspection readiness and driving continuous improvement initiatives. Operating in a fully remote and global environment, you will contribute to a culture of quality, integrity, and patient-centric outcomes. The role requires strong analytical thinking, attention to detail, and the ability to influence across teams. This is an opportunity to make a meaningful impact on the development of therapies that improve patient lives worldwide.

• Provide expert guidance to clinical study teams on GCP compliance, regulatory requirements, and internal SOPs throughout the study lifecycle.
• Conduct risk-based assessments to identify priority studies, high-risk vendors, and key compliance areas requiring attention.
• Monitor, identify, and escalate quality and compliance issues, including assessment and reporting of serious breaches.
• Collaborate with cross-functional stakeholders and external partners to ensure consistent compliance standards and effective governance.
• Support audit and inspection readiness by preparing teams, reviewing documentation, and ensuring alignment with regulatory expectations.
• Contribute to the development and execution of CAPA plans, root cause analyses, and quality improvement initiatives.
• Participate in vendor evaluations and maintain strong relationships with CRO quality teams to monitor ongoing compliance.
• Analyze trends in compliance data and recommend proactive, risk-managed solutions to enhance quality systems.

Requirements:

• Minimum of 5 years of experience in the pharmaceutical, biotechnology, or clinical research industry, including at least 3 years in compliance, quality assurance, or regulatory roles.
• Strong knowledge of clinical trial processes and drug development lifecycle.
• In-depth understanding of ICH GCP guidelines and international regulatory requirements.
• Experience with CAPA management, risk assessment methodologies, and regulatory inspection processes.
• Strong analytical and problem-solving skills with the ability to identify risks and propose effective mitigation strategies.
• Excellent communication and stakeholder management skills, with the ability to influence cross-functional teams.
• Ability to work independently in a remote environment while collaborating with global teams.
• Detail-oriented mindset with a strong commitment to quality and compliance excellence.

Benefits:

• Competitive salary package aligned with experience and market standards.
• Fully remote, home-based work model offering flexibility and autonomy.
• Opportunity to work on global clinical trials across diverse therapeutic areas.
• Exposure to cross-functional teams and international regulatory environments.
• Professional development and career growth opportunities within a dynamic organization.
• Supportive and collaborative work culture focused on innovation and patient impact.