Site and Monitoring Health Lead

Parexel

. Implement the client’s Site and Monitoring Health strategy in alignment with ICH GCP E6 and E8 .

Posted 11/6/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Research Oversight, Risk-Based Quality Management, and regulatory compliance with ICH GCP standards. Proven ability to build relationships with investigators, manage oversight activities, and support clinical site delivery.

Highest-signal resume keywords

Clinical Research OversightRisk-Based Quality ManagementICH GCP ComplianceMonitoring ExperienceInterpersonal Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchRisk AnalysisData ReviewSite MonitoringRegulatory ComplianceAudit ExperienceTrend AnalysisIssue ManagementStudy Phases ExperienceRoot Cause Analysis

Soft Skills

Interpersonal SkillsCommunication SkillsOrganizational SkillsDecision-MakingJudgment

Tools & Technologies

Microsoft ApplicationsClinical Trial Management SystemsData Management Systems

Industry Keywords

GCPCROClinical TrialsMultinational StudiesInspection ReadinessSponsor OversightRecruitment ReadinessSite AssessmentRisk MAPsSSOP

About the role

Key responsibilities & impact

Implement the client’s Site and Monitoring Health strategy in alignment with ICH GCP E6 and E8
Apply risk-based thinking and maintain an inspection-ready mentality
Create or follow Study Specific Oversight Plans for aligned trials
Conduct site risk analyses, site contacts, aggregate data reviews, monitoring visit report reviews, Sponsor Oversight Visits, system/data spot checks, and periodic summaries
Document and file oversight activities in a timely manner
Build relationships with investigators and site staff and identify potential sites for new studies
Use root cause analysis to assess issues and recommend risk-mitigation actions
Support less experienced investigator sites and help ensure recruitment readiness
Troubleshoot and use innovative approaches to resolve clinical site delivery and quality issues
Collaborate with Clinical Risk & Analytics staff on Risk MAPs, SSOP alignment, and outlier site assessment
Lead oversight and trend meetings with study teams and CROs
Complete Sponsor Oversight Visit reports on time and to a high standard
Work independently and collaboratively with cross-functional teams
Support inspection preparation and management
Maintain awareness of changes in industry and regulatory GCP standards
Travel approximately 50%, including potentially local, regional, and international travel

Requirements

What you’ll need

Bachelor's Degree is required
Previous direct monitoring experience with a CRO or pharmaceutical company working on multinational clinical studies
Direct experience managing and overseeing trends in Risk Based Quality Management model / issue management
Experience in all study phases of clinical research (Phase I-III)
Comprehensive and current regulatory knowledge, including GCPs
Lead CRA/management experience preferred
Experience in both prevalent and rare medical conditions preferred
Previous audit and regulatory inspection experience preferred
Flexibility in schedule and willingness to travel frequently
Excellent interpersonal, verbal, and written communication skills
Ability to build and maintain relationships with investigators and sites
Experience with Microsoft-based applications and ability to learn internal and external computer systems
Good organizational skills and ability to deal with competing priorities
Ability to analyze complex situations and communicate issues and recommendations
Good judgment and decision-making experience
Fluency in multiple languages and cultural awareness is a plus

Benefits

Comp & perks

Equal opportunity employer
Consideration without regard to legally protected status