Country Study Operations Manager I

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

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

• Supports Global Study Managers and the larger study management delivery of the study by leading specific parts of the project • Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution • Ensures compliance to relevant global and local, internal and external requirements, and regulations • Provides protocol level guidance and support to responsible local study team members as applicable

🎯 Requirements

• Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required • Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required • Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team • 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 • Fluency in written and spoken English required

🏖️ Benefits

• Health insurance • Professional development opportunities