Director, Process, Standards and Signal Interpretation Lead

Primary role Summary :

The PSSI Lead supports the processes associated with start-up, site monitoring, oversight and site engagement but strives to identify innovative continuous improvement opportunities with keen business analytics. They are responsible to develop and review KPI s and metrics associated with start-up, site monitoring (onsite, remote and central) and site monitoring oversight. With KPIs established, this role will need to continually monitor performance and critically assess their impact and collaborate 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 & Partner follow-up in collaboration with Clinical Compliance.
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 of monitoring teams.

• Foster close collaboration with Clinical Compliance and Clinical Quality Assurance (CQA), Data Management and TES as 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 .

Main Responsibilities

Data and Business Analysis:

• This role involves 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 proactively to ensure a consistent understanding of signals and metrics surfacing and influence the organization and CRO partners to drive process improvements and standardization.
• Critically, this role collaborates with leaders at our wCRO Partners, Clinical Compliance and CQA on monitoring and oversight processes.
• Responsible for working cross functionally to drive consistency and efficiencies, and identify opportunities for site related process improvement in response to, but not limited to, compliance changes, external influences such as regulatory inspections, business strategy, performance signals, feedback from stakeholders, 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 mgt and CAPA resolution where appropriate.
• Leads discussions with tech enablement groups both within CSL and at CRO partners to optimize AI innovations around study start-up, monitoring and monitoring oversight

Qualifications and Experience Requirements

• 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…