Position Description and Summary
The Site Management and Monitoring Oversight is accountable for the strategic and operational oversight of investigational site management and monitoring activities across assigned clinical studies or programs. This role ensures that clinical trials are executed with high quality, regulatory compliance, and operational efficiency, in alignment with global clinical development strategies. Operating within a matrix environment, this role partners with internal stakeholders and external service providers to develop and implement study-specific oversight plans, monitor site performance, and proactively identify and mitigate risks. The role is pivotal in maintaining sponsor oversight, validating the effectiveness of study and site-level activities, and ensuring that monitoring plans and tools adequately address protocol-specific risks.
Main Responsibilities
Clinical Oversight & Compliance
Responsible for operational oversight of the site, site health and monitoring activities
Support QA audit and inspection planning, and implementation of CAPAs as needed
Identify and proactively mitigate site-level risks impacting recruitment, retention, data quality, or compliance, in partnership with CROs
Study Delivery Support
Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts
Support...