Clinical Compliance Manager

This is a fully remote position, open to applicants in Spain, +1 more country.

📋 Description

• Deliver GCP compliance support to clinical study teams under the guidance of the Sr. Manager or Associate Director.

• Offer expertise and advice on regulatory requirements, GCP guidelines, and sponsor SOPs for clinical studies.

• Employ a risk-based approach to prioritize compliance support for clinical activities.

• Recognize and escalate compliance issues while aiding in decision-making processes.

• Assist in the development and implementation of action plans to address quality and compliance risks.

• Serve as a Clinical Compliance representative for clinical study teams in relevant Therapeutic Areas.

• Build relationships with R&D personnel and provide coaching and compliance advice.

• Collaborate on continuous risk assessments of clinical trial activities.

• Identify priority studies, compliance metrics, high-risk vendors, and essential compliance activities.

• Detect and escalate significant quality and compliance issues, including evaluations of serious breaches.

• Participate in CRO/vendor governance teams and vendor evaluations as a subject matter expert.

• Assist clinical teams in drafting responses and CAPAs to audit findings.

• Support Quality Management System activities, including deviation self-reporting, root cause analysis, and CAPA plan development and assessment.

• Identify trends in quality issues and collaborate on risk-managed solutions.

• Lead and manage inspection readiness activities, ensuring that project teams are trained and prepared for regulatory inspections.

⛳️ Requirements

• A minimum of 5 years of clinical operational experience, such as clinical trial manager, clinical compliance manager, or clinical project manager.

• Experience in a clinical compliance, quality assurance, or regulatory compliance role.

• Comprehensive knowledge and understanding of drug development and the clinical trial process.

• Profound understanding of current regulatory and ICH GCP requirements.

• Experience with international regulations, guidelines, and standards.

• Familiarity with CAPA management, risk management, and regulatory inspections.

🏝️ Benefits

• 100% remote home-based position.

• Sponsor-dedicated role.