GCP QA Consultant

In this role you will support quality assurance activities for oncology-focused phase 2-3 clinical trials, ensuring adherence to ICH-GCP and regulatory requirements while maintaining inspection readiness. You will work with cross-functional teams to monitor study quality, manage risk, and drive transparent quality communications. The position emphasizes collaboration with external partners, TMF integrity, and continuous improvement of QA processes. You will mentor colleagues and contribute to regulatory submissions and inspections, making a tangible impact on trial quality and patient safety.

• Develop and oversee study quality plans, including oversight quality and audit plans
• Collaborate with third parties to formalize Investigator Site Audits (ISA) and agendas
• Oversee quality activities for phase 2-3 trials with focus on risk management and endpoint de-risking
• Conduct risk-based reviews of study documents for protocol, ICH-GCP, and regulatory compliance
• Participate in process audits and act as Clinical Quality Assurance Representative at monitor-site meetings
• Ensure effective site monitoring and recommend improvements for site and monitor performance
• Maintain adherence to study plans, SOPs, and transparent communication of quality events
• Ensure clinical trial trackers are updated and maintained by the clinical operations team
• Own and maintain the Clinical Trial Oversight Plan and Clinical Quality Plan
• Ensure Clinical Trial Agreements are in place and TMF documentation reflects site activity
• Collaborate with TMF specialists to keep TMF inspection-ready
• Raise deviations, enforce corrective actions, and recommend improvements
• Issue summary reports based on site/monitor performance and define KPIs
• Escalate suspected serious breaches to senior leadership
• Review Change Control impacts on clinical study materials/tools
• Develop and implement inspection readiness programs for sites and internal staff
• Mentor and lead other Quality Assurance GCP Specialists
• Work with Regulatory Affairs on updated submissions or reporting to CTIS-ClinicalTrials

• Strong knowledge of ICH-GCP guidelines and regulatory requirements
• Experience in QA for phase 2-3 oncology clinical trials
• Proficiency in risk management and endpoint de-risking strategies
• Ability to conduct risk-based document reviews and participate in process audits
• Skilled in developing and maintaining clinical trial plans and trackers
• Familiarity with TMF management and inspection readiness activities
• Effective communication and collaboration across cross-functional teams
• Proven ability to mentor and lead QA professionals
• Experience with regulatory submissions and reporting processes

• effective communication
• collaboration across cross-functional teams
• leadership/mentoring
• ICH-GCP
• risk management
• endpoint de-risking