Clinical Trial Leader – Senior Project Leader

🔥 0 minutes 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

• Provide strategic leadership and end-to-end oversight of complex global Oncology and Inflammation clinical trials • Lead trial setup, execution, delivery, planning, implementation, tracking, and risk mitigation • Direct core and extended trial teams and communicate trial status to stakeholders • Oversee trial feasibility, country allocation, engagement plans, recruitment planning, and risk mitigation • Lead development of core trial and patient-facing documents • Oversee vendor outsourcing, selection, scopes of work, and vendor services • Ensure trial processes support delivery milestones, including quality monitoring, safety reporting, data management, investigational medicinal product, budgets, and site monitoring • Support regulatory authority and ethics committee responses and provide trial team training • Maintain oversight of trial conduct, GCP and regulatory compliance, SOP adherence, and continuous risk monitoring • Monitor patient recruitment and endpoint accrual and implement contingencies • Coordinate clinical trial data cleaning, Clinical Trial Report delivery, TMF archiving, and registry disclosures • Support trial strategy, milestone planning, operational and scientific input, regulatory interactions, and feasibility activities • Foster learning, innovation, empowerment, and high-performance teams • Complete required training, timesheets, expense reports, CV updates, and comply with Parexel processes and applicable requirements

🎯 Requirements

• 5+ years of full-scope global clinical trial project management experience • In-depth understanding of project management and high-performance teamwork • Required experience in Oncology or Inflammation Phase III trials • Understanding of major regulations including US FDA, EMA, and PMDA • Cross-geographical experience in multicultural environments • Strong understanding of corporate culture and cross-cultural dynamics • Strengths in mentoring and coaching • Demonstrated agility, accountability, and intrapreneurship, including fast decision-making, flexibility, ownership, outcome-based thinking, results orientation, and smart risk-taking • University degree, such as a bachelor’s or advanced degree, with a major focus in Biomedical Life Sciences • Scientific and therapeutic knowledge and operational expertise across clinical trial planning and execution • Strong communication, active listening, and cultural awareness • Leadership, strategic thinking, coordination, oversight, and project management capabilities