Director, Process, Standards and Signal Interpretation Lead

About This Role

The PSSI Lead supports and identifies innovative continuous improvement opportunities for processes associated with start-up, site monitoring, oversight, and site engagement using keen business analytics and performance metrics. This role monitors enterprise-level performance and ensures compliance in collaboration with various internal and external stakeholders.

Responsibilities

• Develop and review KPIs and metrics associated with start-up, site monitoring (onsite, remote, central), and site monitoring oversight
• Continually monitor performance, assess impact, identify trends, and resolve issues with appropriate groups
• Monitor start-up, site monitoring, and oversight processes at the enterprise level using dashboards and analytics
• Ensure compliance through SMMO & Partner follow-up in collaboration with Clinical Compliance
• Represent SMMO on SOP and process reviews, determining impact and providing recommendations for process improvements
• Provide high-level oversight of CRO partner monitoring strategies for alignment on risk-based approaches and data verification
• Ensure functional area monitoring is coordinated within CSL and CRO Partner for transparency of issues and required action
• Foster close collaboration with Clinical Compliance, CQA, Data Management, and TES as the point of contact for SMMO
• Champion the implementation and use of harmonized, consistent processes and standards across SMMO deliverables
• Serve as the initial point of contact and technical expert for questions about monitoring and oversight processes, systems, and responsibilities

Requirements

• Extensive experience in global clinical trials and site management
• Strong understanding of Good Clinical Practices (GCPs) and regulatory operations
• Minimum of 10 years experience in site monitoring or central monitoring process development
• Strong analytical thinking and problem-solving skills
• Experience with modelling and AI
• Ability to lead discussions, build consensus, and influence cross-functional teams
• Experience in managing processes with a continuous improvement approach
• Ability to think strategically and to quickly analyze complex circumstances and problems

Qualifications

• 10+ years experience in site monitoring or central monitoring process development

Skills

* Required skills

Benefits