Site and Monitoring Health Lead

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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

• 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

• Equal opportunity employer • Consideration without regard to legally protected status

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