Site and Monitoring Health Lead

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🇬🇧 United Kingdom – 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

• Lead oversight of CRO monitoring effectiveness through site risk analyses, site contacts, monitoring visit report reviews, sponsor oversight visits, system and data spot checks, aggregate data reviews, and periodic quality assessments • Complete Sponsor Oversight Visit reports to a high standard and within established timelines • Apply risk-based review of critical-to-quality factors at study and site level • Develop Study Specific Oversight Plans (SSOPs) and execute oversight activities according to approved plans • Identify, investigate, and address risks or quality concerns affecting site performance and clinical trial delivery • Support inspection preparation, audit readiness, and regulatory readiness • Build collaborative relationships with investigators, site staff, CRO partners, and internal cross-functional teams • Support research sites, especially those with less clinical trial experience, with study engagement and participant recruitment • Partner with Clinical Risk and Analytics teams to assess site-level risks and identify emerging trends • Lead oversight and trend review meetings with study teams and CRO partners • Implement Site and Monitoring Health strategies in alignment with ICH-GCP and applicable regulations • Maintain current knowledge of global and local regulatory requirements for clinical trial oversight

🎯 Requirements

• Significant direct monitoring experience with a CRO or pharmaceutical company on multinational clinical studies • Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes • Experience supporting monitoring oversight, risk-based quality management, and clinical study execution • Strong communication, organizational, analytical, and problem-solving skills • Proficiency with Microsoft Office Suite, including Excel, Word, and PowerPoint • Proficiency in written and spoken English • Ability to travel up to 50%, including local, regional, and international travel • Clinical or advanced degree preferred, including RN, MPH, MS, MA, MBA, or PharmD • Lead CRA or management experience preferred • Experience across Phase I to Phase III clinical studies preferred • Experience in prevalent and rare disease clinical research preferred • Previous audit and regulatory inspection experience preferred • Proficiency in local language where applicable preferred

🏖️ Benefits

• Health, Vision & Dental Insurance • Vacation/Holiday/Sick Time • Flexible benefit portal • Car or car allowance (only applicable roles) • Flexible work arrangements • Growth opportunities