Clinical Trial Specialist / Senior Clinical Trial Associate

2 hours ago

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Parexel

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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.

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Support moderately complex clinical study activities in support of the Clinical Trial Manager • Work closely with the clinical trial team to ensure trial activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's • May assist with vendor oversight and management with guidance • Identify issues in a timely manner and escalate to management as appropriate • Oversight of TMF • May complete monitoring visit report review and perform co-monitoring or monitoring oversight visits

🎯 Requirements

• At least 2 years of experience (3yrs preferred) in clinical studies (Pharmaceutical Industry Experience Preferred) • Previous site monitoring or study coordinator experience is preferred • Working knowledge of Good Clinical Practices (GCP) regulations and Standard Operating Procedures • Understanding of study phases and general knowledge of how they apply to clinical development • Demonstrated ability to work independently and in a team environment • Working knowledge of electronic Systems including Trial Master File, CTMS, etc. (e.g., Veeva Vault, Smartsheet, SharePoint, etc.) • Knowledge of the principles and practices of computer applications in database management • Strong verbal and written communication skills required • 10% - 20% travel may be required.

🏖️ Benefits

• Flexible work arrangements • Professional development opportunities