Clinical Quality Lead

Clinical Quality Lead

argenx

Ghent, Belgium

PURPOSE OF THE FUNCTION

• Act as the quality lead for all Externally Sponsor Research, Non-interventional studies, Early Access Programs, Name Patient Programs and other non traditional clinical studies;
• Drive towards real time quality oversight and consistent high-quality standards of the global clinical trials, both pre and post marketing;
• Support the Clinical Quality Vendor Lead to ensure harmonized quality vendor oversight.

ROLES AND RESPONSIBILITIES

• Serve as primary Quality point of contact for Externally Sponsor Research, Non-interventional studies, Early Access Programs, Name Patient Programs and other non traditional clinical studies;
• Be the Quality point of contact for Global Medical Affairs;
• Lead the GCP quality oversight for assigned trials, collaborating closely with trial teams to uphold high-quality standards;
• Oversee the clinical trial audit programs, including leading the audit site selection process for study-specific audit plans in collaboration with CTT(s), and ensuring timely audit conduct, reporting, review, and closeout in accordance with argenx processes;
• Work with Trial Team to produce GCP quality system metrics for real-time quality monitoring and reporting (e.g., audits, deviations, CAPAs), and conduct trend analysis for management reporting;
• Drive the investigation of trial quality events and define necessary corrective and preventive measures;
• Lead clinical trial inspection readiness activities to ensure preparedness;
• Provide QA input during the creation/revision of argenx clinical procedural documents for GCP compliance;
• Oversee the relationship and performance of clinical partners/vendors to maintain quality standards (incl. vendor qualification).

SKILLS AND COMPETENCIES

• Experience in Quality Oversight for Externally Sponsor Research, Non-interventional studies, Early Access Programs, Name Patient Programs and other non traditional clinical studies;
• In‐depth knowledge of all Clinical Trial related FDA and EU regulations and ICH Guidelines;
• Ability to create a comprehensive study quality oversight plan and audit program and lead the execution thereof;
• Stakeholder management skills.

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Minimum 7 years clinical trial experience;
• Minimum 5 years quality assurance experience;
• FDA, EMA, MHRA, PDMA Inspection experience;
• Capable of building effective relationships with internal and external stakeholders;
• Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timeline;
• Life science educational background;
• Fluent in English.

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Belgium      Clinical Research      On-site      Quality Assurance      argenx