Clinical Operations Excellence Lead

il y a 4 jours

Gent, Belgique Argenx Temps plein

ROLES AND RESPONSIBILITIES:

- Ensure oversight of the adequacy of processes in Global Clinical Operations. Ensure regulatory requirements and commitments are reflected in the procedural documents
- Identify and drive continuous improvement of processes and systems within Global Clinical Operations organization
- Ensure quality risk management principles are integrated in all Global Clinical Operations processes and systems in order to support compliance and ensure inspection readiness throughout
- Drive the investigations and development of CAPA plans related to process-level non-compliances, audit and inspection findings, within the Global Clinical Operations organization
- Actively contribute to a feedback culture on non-compliance, CAPA, inspection and audit findings. Identify opportunities to share knowledge and expertise
- Actively participate in defining and monitoring compliance and quality metrics to ensure compliance oversight in Global Clinical Operations processes and projects
- Identify and implement leading edge technologies and methodologies to enable quality by design of clinical study activities
- Active member of the Global Clinical Operations leadership team to ensure alignment across functions and regular review of the inspection readiness status
- Lead and/or contribute to cross-functional and/or cross-company initiatives aiming to increase quality and compliance, while decreasing rework
- Ensure alignment with the QA organization
- Act as interface between Global Clinical Operations and stakeholder organizations/functions in clinical development
- Foster co-creative working relations with partnering organizations such as QA, BIS, Clinical Development, GPS, GRA

SKILLS AND COMPETENCIES:

- Extensive experience of GCP/Pharmacovigilance quality management systems, applicable regulatory rules and guidelines, medical terminology, clinical trials, and drug development
- Excellent interpersonal negotiation and leadership skills
- Strong written and verbal communication skills, acting globally in a culturally-diverse dynamic team
- Ability to act independently and effectively prioritize
- Root Cause Analysis, CAPA Development and Risk Management methodology expertise

EDUCATION, EXPERIENCE AND QUALIFICATION:

- Bachelor’s degree or University degree - medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience
- Minimum of 10 years of experience in Clinical and/or Pharmacovigilance Quality Management
- Working knowledge of the relationship and regulatory obligations of pharmaceutical/biotech companies and CROs
- Global Strategic Drug Development experience

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