GCP QA Consultant / GCP QA Consultantess

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Become a vital part of a dynamic team driving sales success in the European diabetes care market. Proclinical is currently seeking a GCP QA Consultant to support quality assurance activities for oncology-focused phase 2-3 clinical trials. This position emphasizes risk management, compliance with ICH-GCP and regulatory requirements, and ensuring inspection readiness.

As a GCP QA Consultant, you will collaborate with cross-functional teams to maintain study quality, monitor performance, and ensure transparent communication between clinical operations and quality assurance.

Responsibilities

• Develop and oversee study quality-related plans, including quality oversight and audit plans.
• Collaborate with third parties to formalize Investigator Site Audits (ISA) and agendas.
• Oversee quality activities for phase 2-3 trials, focusing 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 Standard Operating Procedures (SOPs), 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 established and adhered to, with documentation of site feasibility, qualification, initiation, and activation in the Trial Master File (TMF).
• Collaborate with TMF specialists to keep the TMF inspection-ready and accurately reflect study documents.
• Raise deviations, enforce corrective actions, and recommend necessary improvements.
• Issue summary reports based on site and monitor performance, defining and measuring Key Performance Indicators (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.

Apply Now

If you are interested in this exciting opportunity, please apply online using the form below. Please note that only applications matching the job profile will be considered.

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