Global Clinical Trial Lead – FSP, Oncology or Inflammation

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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 set-up, execution, and delivery of assigned phase 3 Oncology or Inflammation clinical trials • Provide leadership and direction to the trial team and ensure overall trial success against milestones and KPIs • Manage planning, implementation, tracking, risk mitigation, and trial status communications • Plan operationally feasible timelines and oversee trial preparation • Support development of trial-level documents across functions • Verify country allocation and oversee trial feasibility • Develop and implement engagement plans, recruitment planning, and risk mitigation • Lead development of core trial and patient-facing documents • Maintain oversight of trial conduct, GCP adherence, regulatory compliance, SOP compliance, and risk monitoring • Support budget oversight, clinical quality monitoring, SMC/DMC management, and safety reporting • Prepare and implement core-document amendments and training updates • Support authority and ethics responses • Oversee vendor services outsourcing, including Central Lab services • Ensure timely cleaning and delivery of clinical trial data • Coordinate with the trial medical writer on the Clinical Trial Report • Ensure complete and compliant archiving of global documents in the TMF • Support global registry disclosure and potential publication of trial data

🎯 Requirements

• Minimum of 5 years of relevant clinical trial management experience • Strong clinical trial project management experience • In-depth understanding of project management, with emphasis on teamwork and promoting high-performance teams • Experience in Oncology and/or Inflammation • Extensive clinical trial project management experience across international trials • Master's degree ideal but not essential