Clinical Compliance Manager

Role Overview

• Provide GCP compliance support to clinical study teams under the direction of the Sr. Manager or the Associate Director
• Act as a Clinical Compliance member of clinical study teams for relevant Therapeutic Areas
• 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
• Participate in vendor evaluations as a Subject Matter Expert (SME) as needed
• Support clinical teams/functions in drafting 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 CAPA plan development and evaluation
• Identify and anticipate trends in quality issues and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion
• Lead/manage inspection readiness activities and ensure project teams are trained and prepared for regulatory inspections.

Requirements

• Minimum of 5 years in the academic, pharmaceutical or biotechnology industry experience, with 3+ years 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.

Tech Stack

• Google Cloud Platform

Benefits

• Parexel supports clinical studies across the full range of therapeutic areas
• We have longstanding partnerships with a vast client base.