Director, Process, Standards and Signal Interpretation Lead

Overview

Primary Role Summary The PSSI Lead supports the processes associated with start-up, site monitoring, oversight and site engagement and strives to identify innovative continuous improvement opportunities with keen business analytics. They are responsible for developing and reviewing KPIs and metrics associated with start-up, site monitoring (onsite, remote and central) and site monitoring oversight. With KPIs established, this role continually monitors performance, critically assesses impact, and collaborates with appropriate groups and the SMMO LT to identify trends and resolve issues and delinquencies.

The PSSI Lead monitors start-up, site monitoring and oversight processes at enterprise level using dashboards and analytics and ensures compliance through SMMO and Partner follow-up in collaboration with Clinical Compliance.

Overview Note The PSSI Lead represents SMMO on SOP and process reviews, determines impact and provides recommendations or process improvement suggestions as needed. Sets oversight strategies that are fit for purpose.

• Ensures that the monitoring oversight process is risk-based, fit for purpose and aligned with the study Compliance Oversight Plans, optimizing resource availability to focus on value-add tasks.
• Provides high-level oversight of CRO partner monitoring strategies for alignment on risk-based approaches, appropriate onsite and remote visit frequencies, and percentages of source data verification and source data review.
• Ensures functional area monitoring (data management review, medical monitoring, statistical review, RBQM review) is appropriately coordinated within CSL and CRO Partner for transparency of issues and required action by monitoring teams.
• Foster close collaboration with Clinical Compliance and Clinical Quality Assurance (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 related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals.

Data and Business Analysis

• Developing and reviewing SMMO-owned operational metrics, study plan variances, and trend reports to identify issues and recommend mitigations.
• Developing innovative, flexible and sustainable practices to drive excellence in SMMO delivery.
• Reviews start-up, monitoring, engagement and site management oversight metrics across the organization/enterprise/portfolio for trends and provides summaries and recommendations to SMMO LT to drive business practice and adoption.

Processes Improvement, Site Quality And Compliance

• The PSSI Lead works closely with stakeholders to ensure a consistent understanding of signals and metrics surfacing and influence the organization and CRO partners to drive process improvements and standardization.
• Collaborates with leaders at wCRO Partners, Clinical Compliance and CQA on monitoring and oversight processes.
• Works cross-functionally to drive consistency and efficiencies, and identify opportunities for site-related process improvement in response to compliance changes, regulatory inspections, business strategy, performance signals, stakeholder feedback, and industry benchmarks.
• Serves as the initial point of contact and technical expert for questions about monitoring and oversight related processes, systems and responsibilities.
• Serves as the SMMO process point person for trending site-related deviations and trend analysis, evaluating and supporting inspection readiness, inspections and audit findings; supporting observation management and CAPA resolution where appropriate.
• Leads discussions with tech enablement groups within CSL and at CRO partners to optimize AI innovations around study start-up, monitoring and monitoring oversight.

• A seasoned clinical trials expert with extensive experience in global clinical trials and site management, with a strong understanding of Good Clinical Practices (GCPs) and regulatory operations.
• Minimum of 10 years experience in site monitoring or central monitoring process development.
• Analytical skills: strong analytical thinking and problem-solving abilities to interpret complex data trends and identify risks.
• Tech and systems savvy; experience in modelling and AI.
• Maintains scientific/operational knowledge and expertise to discuss with higher-level management and peers.
• Strong interpersonal skills – establishes strong relationships with customers.
• Leadership: ability to lead discussions, build consensus, and influence cross-functional teams.
• Creativity and/or ability to implement innovative approaches in clinical development.
• Strategic thinking and targeted problem-solving skills.
• Demonstrated ability to navigate and negotiate competing priorities in a challenging environment.
• Experience in managing processes with a continuous improvement approach.
• Ability to think strategically and quickly analyze complex circumstances and…