Provide GCP compliance support to clinical study teams under the direction of the Sr. Manager or the Associate Director.
Develop strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as needed.
Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity to identify priority studies, compliance metrics for tracking, high-risk vendors, and key compliance activities (i.e., protocol review, vendor evaluations, inspection readiness).
Identify and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the assessment of serious breaches.
Participate as a member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies.
Establish a relationship with CRO Quality Team members for the ongoing review of quality and compliance issues.

Minimum 5 years clinical operational experience, e.g. clinical trial manager, clinical compliance, clinical project manager, etc.
Experience in a clinical compliance, quality assurance, or regulatory compliance role.
Thorough knowledge and understanding of drug development and the clinical trial process.
In-depth knowledge of current regulatory and ICH GCP requirements and experience with international regulations, guidelines and standards is required.
Working knowledge of CAPA management, risk management, regulatory inspections.

Clinical Compliance Manager – FSP

Key skills