QA Clinical Lead (RE-34347985) Ghent, Belgium
Salary: EUR3500 - EUR8000 per annum + Extralegal benefits
Job Description: Clinical Quality Operations Lead
Position Overview: We are seeking a highly skilled and motivated Clinical Quality Operations Lead to join our team. This role will be instrumental in driving continuous improvement projects impacting clinical quality and ensuring compliance with new regulations. The ideal candidate will act as the quality lead for various research programs and non-traditional clinical studies, maintaining high-quality standards and real-time oversight of global clinical trials both pre and post-marketing.
Location: Remote, with the ability to travel to Ghent as needed. Belgian-based candidates preferred.
Reporting Line: Head of Clinical Quality
Key Responsibilities:
1. Serve as the primary Quality point of contact for Externally Sponsored Research, Non-interventional studies, Early Access Programs, Name Patient Programs, and other non-traditional clinical studies.
2. Act as the Quality point of contact for Global Medical Affairs.
3. Provide QA input into assigned continuous improvement projects, including QA audit and process strategy, procedural document review, and regulatory implementation.
4. Drive the risk-based Clinical Internal Audit Plan.
5. Provide metrics and trends for continuous improvement, sharing lessons learned and best practices.
6. Lead the investigation of trial quality events and define necessary corrective and preventive measures.
7. Coordinate the Serious Breach Process.
8. Support unblinded investigations.
Skills and Competencies:
1. Extensive experience in Good Clinical Practices and clinical quality roles.
2. Proven experience in Quality Oversight for Externally Sponsored Research, Non-interventional studies, Early Access Programs, Name Patient Programs, and other non-traditional clinical studies.
3. Strong background in Continuous Improvement projects.
4. In-depth knowledge of Clinical Trial-related regulations (e.g., FDA, EU) and ICH guidelines.
5. Ability to create and execute a comprehensive study quality oversight plan and audit program.
6. Ability to lead, motivate, and educate the Clinical Trial Team (CTT) on clinical quality aspects.
7. Excellent relationship-building skills with internal and external stakeholders.
8. Ability to thrive in a dynamic and fast-growing biotech environment with challenging timelines.
Education, Experience, and Qualifications:
1. A background in Life Sciences.
Application Process: If you are passionate about clinical quality and meet the above qualifications, we encourage you to apply for this exciting opportunity. Please submit your resume and a cover letter detailing your relevant experience and why you are the perfect fit for this role.
Name: Please include your first and last name.
Email: @
Phone: Please include your country code.
CV / Resume:
Yes, I am currently eligible to work (work permit/visa/citizenship) in the country to which I am applying. No, I am not currently eligible to work (work permit/visa/citizenship) in the country to which I am applying.
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