Site and Monitoring Health Lead (FSP)

Job overview

The Site and Monitoring Health Lead (FSP) role is onsite in Boston, MA. Compensation is not specified. The role supports a client's Site and Monitoring Health Team in overseeing clinical trial quality at investigator sites. The role applies monitoring experience and regulatory and Good Clinical Practice knowledge to support quality trial execution and effective oversight of CRO monitoring. It coordinates risk-focused oversight activities, site relationships, issue assessment, and inspection readiness to help protect study quality and delivery.

What you'll do

• Implement the client's Site and Monitoring Health strategy in alignment with ICH GCP E6 and E8
• create or follow Study Specific Oversight Plans
• conduct applicable oversight activities, including site risk analysis, site contacts, aggregate data review, monitoring visit report review, Sponsor Oversight Visits, system and data spot checks, and periodic summaries
• document and file activities promptly
• build relationships with investigators and site staff
• use root cause analysis to assess issues and suggest mitigation
• support less experienced research sites
• coordinate with Clinical Risk & Analytics staff
• lead oversight and trend meetings
• complete Sponsor Oversight Visit reports
• support inspection preparation and management
• maintain awareness of GCP regulatory changes. Travel of approximately 50% is required and may fluctuate, including local, regional, and international travel.

What we're looking for

Skills & competencies

site and monitoring health lead

clinical trials

clinical monitoring

good clinical practice

risk-based quality

site oversight

investigator sites

inspection readiness

root cause analysis

boston ma

parexel

travel required

Work arrangement

• Weekend coverage required

Why this role

Approximately 50% travel is required; travel may include local, regional, and international assignments.

About the employer

Parexel is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.