GCP QA Consultant

Drive Quality Assurance Excellence in Global Oncology Research

Join a growing international medical devices organization to play a pivotal role in driving sales success across the European diabetes care market. In this capacity, you will support critical quality assurance activities for oncology-focused phase 2-3 clinical trials. Your primary focus will be on robust risk management, strict compliance with ICH-GCP and regulatory requirements, and maintaining high standards of inspection readiness.

You will collaborate closely with cross-functional teams to ensure study quality, monitor performance metrics, and maintain transparent communication between clinical operations and quality assurance departments.

Core Responsibilities

• Develop and oversee study quality-related 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 a specific focus on risk management and endpoint de-risking.
• Conduct risk-based reviews of study documents to ensure compliance with protocols, ICH-GCP, and regulatory requirements.
• Participate in process audits and serve as the Clinical Quality Assurance Representative at weekly monitor-site meetings.
• Ensure effective site monitoring and recommend improvements for site and monitor performance.
• Maintain adherence to study plans and SOPs, while ensuring transparent communication regarding 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 adhered to, and that site feasibility, qualification, initiation, and activation are documented in the TMF.
• Collaborate with TMF specialists to ensure the TMF remains inspection-ready and accurately reflects study documents.
• Raise deviations, enforce corrective actions, and recommend improvements as needed.
• Issue summary reports based on site and monitor performance, defining and measuring KPIs.
• Escalate suspected serious breaches to senior leadership.
• Review and assess potential impacts of Change Control requests related to clinical study materials or tools.
• Develop and implement inspection readiness programs, supporting sites and internal staff during regulatory inspections.
• Mentor and lead other Quality Assurance GCP Specialists.
• Work with Regulatory Affairs on updated submissions or reporting to CTIS-ClinicalTrials.

Key Skills and Requirements

• Strong knowledge of ICH-GCP guidelines and regulatory requirements.
• Experience in quality assurance for phase 2-3 clinical trials, particularly in oncology.
• 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 skills across cross-functional teams.
• Proven ability to mentor and lead other professionals in quality assurance.
• Experience with regulatory submissions and reporting processes.