Clinical Compliance Manager

Role Overview

• Provide quality leadership and direction to sponsor R&D stakeholders on GCP-related activities/issues and act as GCP expert/consultant for R&D colleagues.
• 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 sponsor 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.
• Maintain a high level of expertise in international GCP regulations and internal Policies and Procedures that may impact drug development.
• Provide support and guidance during and following internal audits and external regulatory inspections (as required).
• Provide expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities.
• Lead / manage inspection readiness activities and ensure project teams are trained and prepared for regulatory inspections.

Requirements

• Bachelor’s degree is required, life science or related discipline preferred.
• Minimum of 5 years in 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 and GLP requirements is a plus.
• Excellent written and verbal communications skills with the ability to influence others and gain commitment.
• Ability to work in an entrepreneurial and fast-paced culture.
• Must be disciplined, detail-oriented, and able to multitask and work efficiently and independently.
• Ability to collaborate and partner with various internal business partners.
• Ability to work in a team environment.
• Highly developed problem-solving skills and the ability to resolve difficult conflicts.

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• 401(k) matching
• Professional development opportunities