Site Monitoring Lead – Clinical Operations

🔥 4 minutes ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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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 the development and execution of trial level site monitoring and oversight strategies, including monitoring risk assessments and site monitoring plans • Provide oversight of CRO delivered site management and monitoring activities to ensure quality, compliance, and timely study execution • Conduct trial level trend analysis, signal detection, risk identification, and issue management to support proactive decision making • Drive a risk based site monitoring approach and ensure monitoring activities align with study objectives and quality requirements • Collaborate with Clinical Trial Managers, Clinical Research Associates, and cross functional stakeholders to support study delivery against milestones and key performance indicators • Participate in the development and maintenance of trial level documents, amendments, training materials, and monitoring related procedures • Lead and contribute to trial oversight meetings, investigator meetings, and cross functional study discussions at global, regional, and local levels • Conduct site and monitoring oversight activities, implement follow up actions, and escalate issues when required • Serve as a subject matter expert on site management and monitoring, providing guidance and training to study teams • Support trial close out activities, including coordination of clinical data delivery and contribution to quality sections of clinical study reports • Facilitate timely responses to monitoring related questions from internal stakeholders, CRO partners, regulatory authorities, and ethics committees • Ensure inspection readiness and ongoing compliance with sponsor obligations, ICH GCP guidelines, SOPs, and regulatory requirements

🎯 Requirements

• University degree (Bachelor's or equivalent) in life sciences or a related field, or several years of equivalent professional education combined with significant experience in site monitoring and site management • Several years of experience in site monitoring, site management, clinical trial operations, or a related clinical research field • Demonstrated scientific and operational expertise across all aspects of clinical trial planning, site monitoring, and execution • Strong knowledge of ICH GCP, regulatory requirements, sponsor oversight responsibilities, and clinical trial processes • Proven ability to oversee complex clinical trials involving multiple sites, countries, vendors, and stakeholders • Strong communication, organizational, training, and problem solving skills • Fluent English language skills, both written and spoken • Strong expertise in site monitoring, clinical trial oversight, and risk based quality management • Experience working within global clinical development and regulated research environments • Ability to influence and collaborate effectively across complex cross functional and matrix teams • Patient focused mindset with commitment to quality, compliance, and operational excellence • Excellent communication, leadership, and stakeholder management skills • Ability to identify risks, solve complex challenges, and drive successful study outcomes • Strong organizational skills and attention to detail within fast paced global clinical programs

🏖️ Benefits

• Health, Vision & Dental Insurance • Vacation/Holiday/Sick Time • Flexible benefit portal • Flexible work arrangement (Remote)