Clinical Site Monitoring Lead

🕒 June 17

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

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

• Oversight of monitoring effectiveness • Implements various types of oversight encounters and activities as applicable including site risk analysis, site contacts, etc. • 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 • Creates Study Specific Oversight Plans (SSOPs) for aligned trials in scope • Troubleshoots and uses alternative and innovative approaches to solve problems impacting clinical site delivery and quality • Supports inspection preparation and management • Builds relationships with investigators and site staff in region; acts as a resource for identifying potential sites for new studies

🎯 Requirements

• Significant direct CRA / monitoring experience gained 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 • Lead CRA experience required • Experience in all study phases of clinical research (Phase I-III) • Proficient with MS Office Suite (Excel, Word, and PowerPoint); able to learn internal and external computer systems • Proficient in written and spoken English required

🏖️ Benefits

• Health insurance • Professional development opportunities