Clinical Compliance Manager – FSP

This is a fully remote position, open to applicants in Poland.

📋 Description

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

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

• Work with stakeholders to perform continuous risk assessments of clinical trial activities to pinpoint priority studies, compliance metrics for monitoring, high-risk vendors, and essential compliance tasks (e.g., protocol reviews, vendor evaluations, and readiness for inspections).

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

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

• Develop a rapport with CRO Quality Team members for the ongoing evaluation of quality and compliance challenges.

⛳️ Requirements

• At least 5 years of clinical operational experience, including roles such as clinical trial manager, clinical compliance, or clinical project manager.

• Background in clinical compliance, quality assurance, or regulatory compliance positions.

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

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

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

🏝️ Benefits

• Flexible work arrangements