Clinical Trial Manager

Job Title: Clinical Trial Manager

Duration: 12 months

Location: Mason OH 45040 (Hybrid)

Shift: Standard (20hrs/week)

Job Summary:

Technical Skills:

• Must Have
• Familiar with Budgets contracts and deploying Informed Consents.
• Flexible Schedule - Able to work both remotely and onsite work 2-3 consecutive days a week.
• Previous Clinical trial manager role and can lead a small team.

Job Description:

• 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.

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.

Skills:

• 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.