Clinical Trial Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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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 integration of project team activities • Manage strategic study operations, including study sites, regulatory submissions, drug supply and use, subject enrollment, regulatory document flow, study timelines, budgets, financial information, performance metrics, and data flow • Provide input on trial-level operational strategies from protocol design through the final clinical study report • Provide input into global subject/patient recruitment plans • Manage CRO and vendor identification and day-to-day operational activities, including setup, statement of work creation, and budget oversight • Create and update critical trial-specific documents • Support development of compound- and protocol-level training materials • Review and provide input into budgets, timelines, and forecasts for assigned clinical studies • Support trial-level inspection readiness activities, including risk identification and mitigation plans • Participate in trial- and department-level process improvement activities • Manage relationships between study sites and vendors • Interface with internal key stakeholders • Support onboarding of new team members • Attend stakeholder meetings and provide operational updates and input

🎯 Requirements

• Bachelor's degree is required • Minimum 5+ years of clinical research experience with a CRO, biotech, or pharmaceutical company working on Phase I–IV global clinical trials • 2–3 years leading aspects of global clinical trials • Experience working with CROs • Excellent decision-making, analytical, and financial management skills • Excellent leadership skills and ability to operate with limited supervision • Experience leading without authority in multifunctional, matrixed, and global environments • Experience mentoring and coaching others • Exceptional organizational skills and ability to manage competing priorities • Strong reasoning and problem-solving abilities • Strong project planning/management, written and verbal communication, and presentation skills • Experience with protocol, informed consent form (ICF), case report form (CRF), and clinical study report (CSR) development and review • Proficiency in MS Office Suite, including Excel, Word, and PowerPoint • Ability to travel approximately 10%

🏖️ Benefits

• Ability to work remotely in the United States • Opportunity to contribute to the development of therapies that benefit patients