Clinical Quality Lead

Aussicht: 110

Update Tag: 07-11-2025

Ort: Ghent East Flanders

Kategorie: Marketing / PR

Industrie:

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Jobinhalt

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

REPORTING LINE

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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