Clinical Trial Manager

Job Description

Job Summary:

• Procedural work and expertise in Application work by combining hands-on experimentation with scientific principles and knowledge from science/engineering education to drive foundational technical understanding and solve technical problems.
• Delivers technical outputs which address critical innovation challenges and completion of key milestones.
• The Clinical Trial Manager (CTM) is a key member of the clinical team with responsibility for defining and managing the quality execution of clinical studies.
• Partner closely with product and technology development to design and execute clinical studies for claims support, credentialing, decision making, and fundamental understanding.
• The CTM role is pivotal for driving robust human testing and clinical trials that are compliant with established governance principles, including ICH-GCP Guidelines.

Duties and Responsibilities:

• Design, implementation, and management of clinical trials, Development of both external and internal networks for the integration of key components of a successful clinical trial.
• Management of study logistics, timelines, and budget/expense tracking.
• Prepare documentation for study placement and clearances, clinical trial protocols, and IRB submissions, as needed.
• Conduct study close out and tasks, including documentation and archiving of study materials.
• Contribute to the development of Standard Operating Procedures and adhere to all aspects of Governance and Quality systems.
• Represent clinical operations are regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed.

Requirements:

• Experience in human testing and the management of Clinical Trials, including a fundamental knowledge of Good Clinical Practices.
• The candidate will have a strong background in a fundamental knowledge of Biology, Chemistry and/or measurement science.