[Remote] Clinical Trial Manager - East Coast

Note: The job is a remote job and is open to candidates in USA. reputed company is a medical technology company advancing the diagnosis and management of coronary artery disease using cutting-edge technology. The Clinical Trial Manager is responsible for overseeing and managing reputed company clinical operational activities at the trial and site level, ensuring clinical studies meet timelines and maintain high quality standards.

Responsibilities

• Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks
• Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
• Participates in and leads process improvement activities reputed company the department and cross functionally, including SOP development
• Conducts study start-up activities including the development of protocols, informed consent forms, reputed company document worksheets, training presentations, etc
• Reviews site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs
• Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management
• reputed company other duties as required for successfully completing studies, as necessary

Skills

• Ability to work in a smaller team environment with a willing, reputed company hands on deck attitude
• Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities
• High attention to detail, accuracy, and quality and able to effectively prioritize multiple projects
• Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
• Excellent written and oral English communication skills required
• Proficiency in computer programs and specifically in reputed company office tools including Word, reputed company and PowerPoint
• Bachelor's degree in science or health reputed company field
• Demonstrated 5 years minimum relevant experience required
• Experience in cardiovascular medical device clinical research a plus

Benefits

• Cash bonus

Company Overview

Company H1B Sponsorship