Early Clinical Scientist – Translational Medicine

🔥 12 hours ago

🗽 New York – Remote

🗽 New York – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Coordinate the design, planning, and execution of early-phase clinical trials with the Clinical Director and internal/external team members • Oversee trials within and/or across programs or therapeutic areas • Ensure excellence in execution and compliance to support study objectives and data validity • Manage internal and external team performance to achieve project objectives • Resolve project performance issues • Ensure appropriate clinical safety assessment and risk management of compounds • Conduct real-time oversight of ongoing trials to identify and mitigate patient, study design, data, or study conduct issues • Review and interpret clinical trial data • Potentially conduct on-site study monitoring, including site training and supervision of complex, novel endpoint/biomarker collection processes • Apply knowledge of GCP, ICH guidelines, and regulatory requirements for clinical development • Co-author clinical sections of protocols, clinical investigator brochures, and clinical study reports • Develop study operational documents, including site monitoring plans, study operations manuals, and informed consents • Manage trial and program projects, team activities, risk assessment, and contingency planning under accelerated timelines • Build knowledge and skills to manage additional early drug development processes and procedures

🎯 Requirements

• Experience in managing CROs from the Sponsor side for Ph1 clinical trials • Use of Clinical Trial Management and Trial Master File systems • Authoring Protocol Concepts • Facilitating a Trial Team including cross functional partners such as regulatory, clinical supplies managers, data managers, statisticians, programmers, procurement, etc. • Managing multiple projects at a time • Reviewing protocols, ICFs, IBs, CSRs, biomarker processes, site and medical monitoring plans, risk assessments, and protocol deviations • Working in Microsoft Teams • Understanding of the clinical research development process from program planning to regulatory submission • Ability to quickly develop working scientific knowledge of different therapeutic areas • Ability to manage complex operations and projects under accelerated timelines • Scientific, medical and/or safety writing and reporting; at least one is required • Ability to partner effectively with internal and external teams to achieve results • Strong team collaboration, leadership, communication, issue identification, and resolution skills • Knowledge of GCP, ICH guidelines, and regulatory requirements • Degree in Life Sciences • Bachelor’s degree and ≥7 years related experience, or Master’s degree and ≥5 years related experience, or PhD/doctorate degree and ≥1 year related experience