Clinical Trials Manager

Vanderbilt Univ Medical Center - Nashville, TN

Full-time - Mid Level

Nashville, TN

About the position

In your pivotal role as a Clinical Trials Manager at Vanderbilt University Medical Center (VUMC), you will be responsible for supporting the design and conduct of operational activities related to planning, implementing, executing, and reporting of multicenter clinical trials. This role requires adherence to standard operating procedures, Good Clinical Practice, and compliance with local and federal regulations. You will ensure data accuracy across participating clinical research sites and direct long-range strategic planning for each clinical trial, including setting goals and objectives. It is essential to ensure that goals and milestones remain on track, and you will develop and implement corrective action plans to improve performance when necessary. The Vanderbilt Coordinating Center (VCC) provides comprehensive, central support for a diverse platform of clinical and translational research projects. Since its inception in 1989, the VCC has evolved to meet the growing needs of Vanderbilt investigators, particularly with the addition of large, innovative clinical trial grants within the Vanderbilt Institute for Clinical and Translational Research (VICTR). As a Clinical Trials Manager, you will manage and operationally deliver clinical elements within a trial, including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, regulatory documentation, data cleaning activities, and close-out. You will work closely with sponsors and other functional team members to ensure appropriate communication and ongoing leadership of assigned trials. Your role will also involve identifying challenges to study timelines and deliverables, offering creative action plans to the team and sponsor, and maintaining team focus on study priorities through efficient cross-functional partnerships. You will be responsible for establishing consistent methods for study communication, fostering collaboration, and improving communication among all stakeholders involved in the clinical trials. This position is critical in ensuring the success of clinical trials and advancing health and wellness through innovative research.

Responsibilities

• Manage and operationally deliver clinical elements within a trial including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, regulatory documentation, data cleaning activities and close-out.
• Ensure appropriate communication and ongoing leadership of assigned trial(s) by working in close collaboration with the sponsor and other functional team members.
• Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor.
• Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction.
• Assist with protocol development from a scientific, statistical, regulatory, and administrative perspective during the conceptual phase of the project.
• Implement processes for proper trial coordination at participating centers and individualize processes when necessary to ensure protocol compliance.
• Develop written, multicenter study plans including Standard Operating Procedures, Monitoring Plans, and Committee Charters to streamline clinical trial workflow.
• Perform ongoing regulatory review for participating Clinical Trial sites to maintain compliance with applicable local, state, and federal laws and best practices.
• Oversee the verification process for the electronic data submitted from national/global Clinical Trial sites.
• Compile data on trial activities and quality of reporting based on contractual terms.

Requirements

• Bachelor's Degree
• 2 years relevant experience in clinical trials management or related field.

Nice-to-haves

• Experience with multicenter clinical trials
• Familiarity with FDA regulations and Good Clinical Practice guidelines
• Strong communication and leadership skills
• Ability to work collaboratively in a team environment
• Experience in data management and analysis.

Benefits

• Comprehensive health insurance
• 401k retirement savings plan
• Paid time off and holidays
• Professional development opportunities
• Diversity and inclusion programs