Parexel
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.
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Parexel
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
• Act as direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase. • Build relationships with investigators and site staff. • Support on request country specific feasibility and/or site pre-qualification and qualification activities. • Manage country and site level TMF issues ensuring documents’ First Time Quality (FTQ). • Develop strategy to configure, distribute, collect, and review high quality country and/or site specific documents. • Customize, review, and negotiate country/site specific Informed Consent Forms (ICF). • Prepare and submit IRB/IEC and MoH/RA applications, resolving conflicts. • Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
🎯 Requirements
• Strong local ethics committee/ Regulatory experience • Strong problem-solving skills • Excellent presentation skills • Client focused approach to work • Strong ability to prioritize multiple tasks and achieve project timelines • Substantial startup experience or equivalent experience in clinical research • Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
🏖️ Benefits
• Health insurance • Professional development opportunities
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