Lead CRA, Oncology

🔥 11 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🪙 Affiliate Manager

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

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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 site start-up and activation activities, including site qualification, pre-trial assessments, site initiation activities, and activation readiness • Support country and site selection processes by providing local intelligence, feasibility insights, and site assessment input • Build and maintain relationships with investigator sites throughout the study lifecycle • Serve as the operational point of contact for site-level questions and coordinate issue resolution across study teams and stakeholders • Ensure completion of required training, documentation, and systems activities for site activation and study execution • Drive site recruitment planning and enrolment support to achieve study and country-level targets • Maintain regular communication with sites to monitor study progress, recruitment performance, and operational deliverables • Review site monitoring reports and support compliance with informed consent documentation and amendments • Oversee site deliverables, including timely data entry, data review, database lock readiness, and investigator documentation • Identify quality, compliance, and operational risks using study data and local intelligence, and implement mitigation plans • Support decentralized trial capabilities and site adoption of study technologies and processes • Collaborate with internal stakeholders to optimize communication, improve site experience, and strengthen study delivery outcomes • Serve as primary point of contact for investigative sites throughout the clinical study lifecycle, from start-up through closeout

🎯 Requirements

• Bachelor’s degree, Registered Nurse qualification, or equivalent combination of education, training, and experience • At least 5 years of experience in clinical research, site management, monitoring, or a related field • Demonstrated experience in site management with prior experience as a Site Monitor/CRA • Demonstrated experience across the full clinical trial lifecycle, from study start-up and site activation through closeout • Knowledge of ICH GCP, applicable regulatory requirements, and clinical trial processes • Experience working with clinical trial systems such as EDC, Shared Investigator Platform, Site Profile, or similar clinical research technologies • Strong relationship building, stakeholder management, communication, organizational, and problem solving skills • Ability to collaborate effectively across cross functional and geographically diverse teams • Patient focused mindset with strong attention to quality, compliance, and operational excellence • Comfort working with clinical trial systems, study oversight processes, and site management activities • Ability to travel regularly throughout the UK, up to 50% • Proficiency in English • Preferred: Experience supporting multinational clinical studies across a range of therapeutic areas • Preferred: Experience contributing to site feasibility, recruitment planning, and study performance optimization • Preferred: Familiarity with decentralized clinical trial capabilities and associated site technologies • Preferred: Subject matter expertise in clinical research systems, processes, or site management practices

🏖️ Benefits

• Medical & Dental Insurance • Life Assurance • Pension • Critical Illness Insurance & Health Screenings • Comprehensive benefits package for eligible employees • Flexible work environment • Growth opportunities