Clinical Compliance Manager – Sponsor Dedicated

📋 Description

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

• Serve as a Clinical Compliance member of clinical study teams for applicable Therapeutic Areas.

• Build strong relationships with R&D personnel across various functions and teams, providing coaching and compliance guidance as necessary.

• Collaborate with stakeholders to carry out ongoing risk assessments of clinical trial activities to pinpoint priority studies, compliance metrics for tracking, high-risk vendors, and essential compliance activities.

• Identify and escalate critical quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the evaluation of serious breaches.

• Participate as a member of Contract Research Organization (CRO)/Vendor governance teams for designated Therapeutic Areas/Studies.

• Establish a rapport with CRO Quality Team members for the continuous review of quality and compliance issues.

• Engage in vendor evaluations as a Subject Matter Expert (SME) as necessary.

• Assist clinical teams/functions in crafting responses and CAPAs to internal and external audit findings.

• Provide support and guidance for Quality Management System activities, including self-reporting deviations, root cause analysis, and the development and evaluation of CAPA plans.

• Identify and foresee trends in quality issues and work with functional management to ensure timely implementation of risk-managed solutions.

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

⛳️ Requirements

• At least 5 years of experience in the academic, pharmaceutical, or biotechnology industry.

• Over 3 years in a clinical compliance, quality assurance, or regulatory compliance role.

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

• Extensive knowledge of current regulatory and ICH GCP requirements, along with experience in international regulations, guidelines, and standards.

• Proficient understanding of CAPA management, risk management, and regulatory inspections.

🏝️ Benefits

• Options for remote work.