Description
Roles and Responsibilities:- Independently lead clinical trial project execution to ensure that trial timelines, costs, and quality metrics are met
- Serves as primary contact for functional area representatives in managing protocol execution
- Oversight for forecasting of clinical supplies, eg study drug
- Oversee ongoing service provider management (e.g., CROs, IVRS, Central Labs), including independent negotiation of scope of work, budgets, performance management, and issue resolution
- Manage adherence to ICH/GCP/local regulations
- Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork
Requirements:
- Bachelor's Degree with 4+ years of clinical research experience
- Broad and current knowledge of regulations, clinical development process and therapeutic area to study plans
- Excellent communication skills to effectively disseminate information within clinical as well as other functional areas as appropriate
- Experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
- Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook
To find out more about Real please visit www.realstaffing.com