Clinical Trial Leader – FSP

🔥 55 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

• Lead the set-up, execution, delivery, and closeout of assigned clinical trials • Provide leadership and direction to core and extended trial team members • Plan, implement, track, and oversee clinical trial activities and risk mitigation • Lead trial preparation, operational feasibility, recruitment planning, engagement plans, and patient-facing documents • Oversee country allocation, trial feasibility, vendor services, trial processes, budgets, quality monitoring, safety reporting, and regulatory/ethics responses • Maintain oversight of trial conduct, including GCP, regulatory requirements, SOP compliance, and continuous 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 clinical data cleaning, delivery, archiving in the TMF, and results/documents disclosure • Coordinate and support preparation of Clinical Trial Reports • Support trial strategy, milestone planning, operational and scientific input, and regulatory interactions • Communicate trial status to stakeholders and escalate issues as appropriate • Liaise with Clinical Trial Managers and internal and external stakeholders globally, across multiple countries or regions

🎯 Requirements

• Strong clinical trial project management experience • In-depth project management understanding, emphasizing teamwork and high-performance teams • Oncology and/or inflammation experience • Understanding of major regulations including US FDA, EMA, and PMDA • Familiarity with guidelines and standard of care is desirable • Cross-geographical experience and understanding of multicultural and cross-cultural dynamics • Strengths in mentoring/coaching • Demonstrated agility, accountability, intrapreneurship, fast decision-making, flexibility, ownership, outcome-based thinking, results orientation, and smart risk-taking • Strong communication, active listening, and cultural awareness skills • Scientific and therapeutic knowledge and operational expertise across clinical trial planning and execution • Extensive international clinical trial project management experience • Leadership and influence capabilities in complex situations • Strategic, visionary, creative, courageous, and analytical mindset • Ability to set priorities, manage activity pace, and use resources efficiently • Effective project planning, prioritization, action definition, transparency, and clarity • University degree, such as a bachelor’s or advanced degree, with a major focus in Biomedical Life Sciences

🏖️ Benefits

• Equal opportunity employer • Global, multicultural work environment • Opportunities for mentoring/coaching and professional development through leadership and team collaboration