Global Clinical Trial Leader – FSP

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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

• Manage planning, implementation, and tracking of clinical trial processes, including risk mitigation • Plan and oversee trial timelines and trial preparation • Support development of trial-level documents owned by Statistics, Data Management, Study Physician, Medical Writing, and Site Monitoring • Verify and provide input into country allocation and oversee trial feasibility • Develop and implement trial engagement plans, recruitment planning, and risk mitigation • Lead development of core trial and patient-facing documents • Maintain oversight during trial conduct, including GCP, regulatory, SOP, and risk-monitoring compliance • Support budget oversight, clinical quality monitoring, SMC/DMC management, and safety reporting • Prepare and implement amendments to core documents, including training updates and retraining • Support responses to authority and ethics requests • Oversee outsourced vendor services, including Central Lab services • Ensure timely cleaning and delivery of clinical trial data • Coordinate and support the trial medical writer in providing the CTR • Ensure timely, complete, and compliant archiving of global documents in the TMF • Support results and document disclosure in global registries • May support publication of trial data

🎯 Requirements

• Degree required; master’s degree preferred • Minimum of 5 years’ experience in clinical trial management • Extensive experience in clinical trial project management across international trials • Global experience in clinical research, healthcare, or a regulated environment • Strong clinical trial project management experience • In-depth understanding of project management and teamwork to promote high-performance teams • Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes • Strong communication, organization, and problem-solving skills • Fluency in English, written and spoken • Experience in Oncology, CNS, Immunology, or Vaccines preferred

🏖️ Benefits

• Flexible work arrangements • Growth and continuous learning opportunities • Opportunities to explore career paths and expand skills across clinical research