Clinical Trial Leader

🕒 3 days 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

• Plan, set up, execute, and deliver assigned clinical trials according to milestones and KPIs • Lead and direct core and extended trial team members • Manage patient and site engagement, recruitment planning, trial feasibility, and risk mitigation • Develop core trial and patient-facing documents and incorporate patient/site feedback • Oversee country allocation, vendors, trial processes, budgets, quality monitoring, safety reporting, and regulatory/ethics responses • Maintain oversight of trial conduct, GCP compliance, regulatory requirements, SOPs, and risk monitoring • Monitor patient recruitment and endpoint accrual and implement contingencies • Coordinate early clinical trial Innovation Unit tasks such as biomarker sampling, genomics, and sub-studies • Ensure timely data cleaning, clinical trial reporting, and compliant TMF archiving • Support results disclosure and publication of trial data • Contribute operational and scientific expertise to trial strategy and feasibility • Communicate trial status to stakeholders and escalate issues as appropriate • Liaise with Clinical Trial Managers and internal and external stakeholders globally

🎯 Requirements

• University degree required, such as a bachelor's or advanced degree, with a major focus in Biomedical Life Sciences • Strong clinical trial project management experience • In-depth understanding of project management and high-performance teamwork • Understanding of major regulations, including US FDA, EMA, and PMDA • Extensive experience in clinical trial project management in an international context • Scientific, therapeutic, and operational expertise across clinical trial planning and execution • Experience managing trial complexity across protocols, patients, sites, countries, and vendors • Strong communication, active listening, and cultural awareness skills • Leadership, mentoring, coaching, coordination, and oversight capabilities • Strategic, analytical, results-oriented, and global mindset • Ability to navigate ambiguity, set priorities, manage resources, resolve challenges, and take smart risks • Experience in therapeutic areas relevant to the client pipeline is desirable • Familiarity with guidelines and standard of care is desirable

🏖️ Benefits

• Equal opportunity employment • Global, multicultural work environment • Continuous learning and best-practice sharing • Innovative technologies and empowerment culture