Clinical Operations Excellence Lead (COEL) - Home-Based (US or Canada)

The Clinical Operations Excellence Lead (COEL) is responsible for the operational implementation of the clinical Quality Management System (QMS) within the Global Clinical Operations organization (including Global Trial Operations, Data Management, Medical Writing, and Global Sourcing & Alliance Management). This will be done in alignment with the global quality strategy, ensuring consistency, effectiveness, and efficiency. The ideal candidate will excel in leadership, cultivating strong internal and external relationships, and fostering effective communication.

• Oversee the adequacy of processes within Global Clinical Operations, ensuring that regulatory requirements and commitments are reflected in procedural documents.
• Drive continuous improvement initiatives for processes and systems within Global Clinical Operations.
• Integrate quality risk management principles into all processes and systems to support compliance and ensure inspection readiness.
• Lead investigations and the development of Corrective and Preventive Action (CAPA) plans in response to process-level non-compliances, audit, and inspection findings within Global Clinical Operations.
• Foster a culture of feedback regarding non-compliance, CAPA, and audit/inspection findings, identifying opportunities to share knowledge and expertise.
• Contribute to defining and monitoring compliance and quality metrics to ensure oversight of Global Clinical Operations processes and projects.
• Prioritize clinical process improvement activities by applying Quality Risk Management and Quality-by-Design principles consistently.
• Identify and implement innovative technologies and methodologies to enable quality-by-design in clinical study activities.
• Serve as an active member of the Global Clinical Operations leadership team to ensure alignment across functions and regular reviews of inspection readiness status.
• Lead or contribute to cross-functional and cross-company initiatives that improve quality and compliance while reducing rework.
• Ensure alignment with the Quality Assurance (QA) organization.
• Act as a liaison between Global Clinical Operations and other stakeholder organizations/functions within clinical development.
• Foster collaborative relationships with partnering organizations such as QA, BIS, Clinical Development, GPS, and GRA.

• Bachelor’s degree or equivalent in a medical or para-medical field (e.g., Biology, Biomedical Sciences, Pharmacy, Veterinary, etc.), or equivalent experience.
• A minimum of 10 years of experience in Clinical Quality Management.
• Working knowledge of the regulatory obligations and relationships between pharmaceutical/biotech companies and Contract Research Organizations (CROs).
• Experience in global strategic drug development.
• Extensive experience with GCP quality management systems, regulatory rules and guidelines, medical terminology, clinical trials, and drug development.
• Strong interpersonal, negotiation, and leadership skills.
• Excellent written and verbal communication skills, with experience working in a culturally diverse, global team.
• Ability to work independently and effectively prioritize tasks.
• Expertise in Root Cause Analysis, CAPA development, and Risk Management methodology.