Senior Director, Clinical Operations Compliance Management

Overview

• Lead compliance management for clinical operations, ensuring adherence to ICH GCP and regulatory standards.
• Drive risk management, issue resolution, and vendor oversight for clinical trials.
• Collaborate with cross-functional teams to streamline processes and enhance operational efficiency.
• Support inspection readiness activities and ensure consistency in study execution.
• Utilize data analysis to identify improvement opportunities and recommend changes.
• Provide leadership in CAPA management and compliance monitoring.
• Act as a liaison between Quality Assurance and other functional teams.
• Ensure processes minimize burden on stakeholders and optimize clinical landscape operations.

Key Responsibilities & Duties

• Develop and implement strategies for risk and issue management in clinical operations.
• Create and maintain functional risk management plans to ensure compliance and readiness.
• Collaborate cross-functionally to address risk management activities and escalate issues.
• Support CAPA owners in assignment, follow-up, and completion of compliance actions.
• Provide updates to leadership on CAPA completion and compliance data.
• Act as a liaison for Quality Assurance and other functional teams across R&D.
• Lead efforts to streamline cross-functional processes and templates for clinical operations.
• Utilize data insights to drive process improvements and operational changes.

Job Requirements

• Bachelor’s degree in a related discipline; advanced degrees preferred.
• Minimum of 15 years of experience in clinical operations or compliance management.
• Proven leadership and management skills in biotech or pharmaceutical industries.
• In-depth knowledge of biopharmaceutical regulations, standards, and best practices.
• Strong analytical, strategic thinking, and problem-solving abilities.
• Excellent interpersonal, verbal, and written communication skills.
• Proficiency in Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook.
• Ability to influence and collaborate across complex supplier landscapes.