Process, Standards and Signal Interpretation Lead
CSL
full-time
Posted on:
Location Type: Office
Location: King of Prussia • Pennsylvania • United States
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Job Level
About the role
- 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.
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 10 years experience in site monitoring or central monitoring process development.
- Strong analytical thinking and problem-solving skills are essential for interpreting complex data trends and identifying risks.
- Tech and systems savvy; experience of modelling and AI
- Maintains scientific/operational knowledge and expertise to possess credibility to discuss with higher level management and peers.
- Strong interpersonal skills - establishes strong relationships with customers.
Benefits
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
KPI developmentsite monitoringperformance monitoringdata analyticsrisk assessmentprocess improvementsource data verificationsource data reviewclinical trial managementregulatory operations
Soft skills
analytical thinkingproblem-solvinginterpersonal skillsrelationship buildingcollaborationcommunicationleadershipcritical assessmentinnovationcredibility
Certifications
Good Clinical Practices (GCP) certification