Jobs in Koblenz, Deutschland

Champion compliance and precision-help deliver life-changing therapies.

Proclinical is seeking a GCP QA Consultant to support quality assurance activities for oncology-focused clinical trials. This role involves overseeing quality processes for phase 2-3 studies, ensuring compliance with ICH-GCP and regulatory requirements, and managing risk-based quality plans. You will collaborate with internal teams and external partners to maintain high standards of clinical trial execution and inspection readiness.

This is a fully remote position, open to candidates located anywhere within Europe.

• 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, 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.
• Act as the Clinical Quality Assurance Representative in weekly monitor-site meetings.
• Monitor site performance, ensuring adherence to monitoring plans, tracking deviations, and recommending improvements.
• Ensure internal operations align with study plans, SOPs, and maintain transparent communication regarding quality events.
• Maintain and update Clinical Trial Oversight Plans and Clinical Quality Plans.
• Ensure proper documentation and adherence to Clinical Trial Agreements, site feasibility, qualification, initiation, and activation processes.
• Collaborate with TMF managers to ensure the Trial Master File (TMF) remains accurate and inspection ready.
• Identify and address deviations, enforce corrective actions, and recommend process improvements.
• Issue performance summary reports, define and measure KPIs, and escalate serious breaches when necessary.
• Support change control requests related to clinical study materials or tools, providing quality input.
• Develop and implement inspection readiness programs, supporting sites and staff during inspections.
• Mentor and lead other Quality Assurance GCP Specialists.
• Work with Regulatory Affairs on updated submissions or reporting requirements.

• Strong knowledge of ICH-GCP guidelines and regulatory requirements.
• Experience in quality assurance for clinical trials, particularly in phase 2-3 studies.
• Proficiency in risk management and quality oversight processes.
• Ability to manage and maintain TMF documentation and ensure inspection readiness.
• Skilled in identifying deviations, implementing corrective actions, and driving process improvements.
• Excellent communication and collaboration skills to work with cross-functional teams and external partners.
• Familiarity with Clinical Trial Agreements, site feasibility, and activation processes.
• Leadership and mentoring abilities to guide junior team members.

If you are having difficulty in applying or if you have any questions, please contact Ingrid Aymes at i.aymes@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

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