Manager, Clinical Compliance and Training

Role Summary

Manager, Clinical Compliance and Training at Nuvation Bio. Responsible for maintaining and enhancing the quality and efficiency of clinical trials, ensuring compliance with regulatory guidelines, policies, SOPs, and GCP standards, and coordinating training for the clinical team.

Responsibilities

• Quality Control and Compliance
• Monitor clinical trial activities to ensure regulatory requirements (FDA, EMA, ICH-GCP) and SOPs are met.
• Conduct regular reviews and quality checks on trial processes, documentation, and deliverables for accuracy and regulatory compliance.
• Oversee clinical system use, maintenance, and end user training.
• Ensure trial-related documentation is inspection-ready and regulatory-compliant; support TMF setup with vendors and TMF transfer at study closure.
• Act as liaison between clinical operations and quality assurance to align on quality standards and goals.
• Analyze key quality metrics to identify trends and areas for improvement.
• Process improvement and Optimization
• Identify areas for process improvement within clinical operations to enhance efficiency and reduce errors.
• Support CAPAs to address quality issues identified during audits or reviews.
• Collaborate with clinical operations to optimize trial processes and align with company goals.
• Use data-driven insights to implement continuous improvement strategies and new technologies/tools.
• Stay updated on industry trends, regulations, and quality management innovations.
• Establish a quality improvement framework to improve trial efficiency and compliance.
• Training and Guidance
• Provide training and support to clinical teams on quality control best practices and regulatory compliance.
• Develop and deliver training on GCP compliance, risk management, and quality improvement initiatives.
• Foster a culture of continuous learning and quality excellence.
• Risk Management and Issue Resolution
• Identify and assess risks related to clinical trial quality and regulatory compliance.
• Ensure risk mitigation strategies for each study to minimize delays or jeopardy to trial success.
• Proactively identify and resolve quality-related issues with study teams.

Qualifications

• Minimum Educational Requirement: Bachelor‚Äôs degree in life sciences, healthcare, or related field; equivalent work experience considered.
• Minimum 5 years of applicable industry experience in drug development; preference for startup environments; experience across Phase 1-3 and US/China is a plus.
• Robust understanding of validated, Part 11 compliant systems.
• Core Competencies: Knowledge of FDA/ICH GCP (E6(R3)); experience in clinical operations and ability to provide training; strong problem-solving and analytical skills; excellent communication and collaboration; attention to detail; ability to work in a fast-paced, innovative environment; proficiency with Microsoft Office; travel up to 5%.

Skills

• Quality control and regulatory compliance
• Process improvement and CAPA management
• Training design and delivery on GCP and quality topics
• Risk assessment and issue resolution
• Data analysis and metrics interpretation
• Cross-functional collaboration
• Documentation and TMF management

Education

• Bachelor‚Äôs degree in life sciences, healthcare, or related field (preferred)

Additional Requirements

• Travel may be required up to 5%