Study Operations Manager

3 days ago

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Logo of Parexel

Parexel

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.

Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• The Study Operations Manager I (SOM I) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on studies of limited complexity (a small number of countries/sites) or manages portions of a larger study (such as recruitment and retention).

🎯 Requirements

• 3-5 years US clinical trial study management experience required • Comprehensive knowledge of own discipline with good knowledge of other disciplines to ensure that the study can meet its goals and to serve as a resource for others • Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team • Working knowledge of Good Clinical Practice, clinical and regulatory operations, and environment in countries under responsibility • Demonstrated clinical research experience and/or study management/startup project manager experience • Demonstrated experience in managing country level operational activities and/or vendors • Experience in study and quality management • Knowledge of clinical trial methodology • Experience working in a matrix management environment

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