
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.
🔥 5 minutes ago
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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.
• Coordinate the design, planning, and execution of early-phase clinical trials with the Clinical Director and internal/external team members • Oversee trials across programs and/or therapeutic areas, ensuring execution quality, compliance, study objectives, and data validity • Manage trial and program projects, team activities, meetings, and document/collaborative workspace management • Manage internal and external team performance and resolve project performance issues • Conduct real-time oversight of ongoing trials to identify and mitigate patient, study design, data, and study conduct issues • Monitor clinical safety assessment and compound risk management • Provide risk assessment and contingency planning under accelerated timelines • Review and interpret clinical trial data • Potentially conduct on-site study monitoring, including site training and supervision of complex endpoint/biomarker collection • 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 • Review budgets and approve vendor invoices as required • Complete required training, timesheets, expense reports, and CV updates • Maintain knowledge of and comply with Parexel processes, ICH-GCPs, and applicable requirements
• MS Office Suite experience required, including Word, Excel, PowerPoint, and Teams • Strong team collaboration, leadership, written and verbal communication, issue identification, and resolution skills • Proficient in written and spoken English • Proficient in local language, as applicable • Ability to manage multiple projects and varied tasks and prioritize workload with attention to detail • Ability to manage complex operations and projects under accelerated timelines • Ability to partner effectively with internal and external teams • Ability to quickly develop working scientific knowledge of different therapeutic areas • Experience managing CROs from the Sponsor side for Phase 1 clinical trials • Experience using Clinical Trial Management and Trial Master File systems • Experience authoring Protocol Concepts • Experience facilitating cross-functional Trial Teams • Experience reviewing protocols, ICFs, IBs, CSRs, biomarker processes, site and medical monitoring plans, risk assessments, and protocol deviations • Understanding of the clinical research development process from program planning to regulatory submission • Scientific, medical, and/or safety writing and reporting experience; at least one is required • Knowledge of GCP, ICH guidelines, and regulatory requirements • Familiarity with early drug development processes • 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
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