Site and Monitoring Health Lead - Northeast US - FSP

Site and Monitoring Health Lead - Northeast US - FSP at Parexel in Boise, Idaho, United States Job Description Candidates must be located in the Northeast US near a major airport. Job Purpose: The Site and Monitoring Health Lead (SMH Lead) will apply knowledge of regulations and GCPs as well as experience in monitoring to safeguard the quality of clinical trial execution at investigator sites and ensure the client’s oversight of CRO monitoring effectiveness. This is a site-facing position that reports to the FSP Manager, with work directed by the client Associate Director (or above), Site and Monitoring Health Team. Key Accountabilities: Oversight of monitoring effectiveness + Implements various types of oversight encounters and activities as applicable including but not limited to site risk analysis, site contacts, aggregate review of data, monitoring visit report review, Sponsor Oversight Visits, system/data spot checks, and periodic summaries; ensure timely documentation of these activities is completed and file + Completes Sponsor Oversite Visit reports consistently on time and with good quality + Utilizes a risk-based approach to review critical to quality items at the site level and study level, exhibiting an “inspection ready at all times” mentality + Creates Study Specific Oversight Plans (SSOPs) for aligned trials in scope and /or follows SSOP when conducting oversight activities + Troubleshoots and uses alternative and innovative approaches to solve problems impacting clinical site delivery and quality + Utilizes root cause analysis to assess identified issues and provide suggested actions to Study Management/Clinical Research Organization (CRO) to mitigate risk + Supports inspection preparation and management Collaborative relationships + Works both independently and collaboratively with cross-functional teams + Builds relationships with investigators and site staff in region; acts as a resource for identifying potential sites for new studies + Supports investigator sites less experienced in research; assists in assuring sites are engaged in the study and have what they need to recruit participants successfully + Works closely with Clinical Risk and Analytics staff to understand the risk management plan (Risk MAP) for assigned studies, ensures the SSOP is aligned with the Risk MAP, and assesses sites who are outliers Operational + Implements client Site and Monitoring Health strategy in alignment with applicable International Council for Harmonization-Good Clinical Practices (ICH-GCP) regulations + Leads oversight a To view full details and how to apply, please login or create a Job Seeker account

Created: 2026-04-15