Clinical Trials Manager

Vanderbilt Health - Nashville, TN

Full-time - Mid Level

Nashville, TN

Hospitals

About the position

As a Clinical Trials Manager at Vanderbilt Health, you will play a crucial role in supporting the design and execution of operational activities related to multicenter clinical trials. Your responsibilities will encompass planning, implementing, executing, and reporting on these trials in accordance with standard operating procedures, Good Clinical Practice, and 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. Your leadership will be vital in ensuring that goals and milestones remain on track, and you will develop and implement corrective action plans to enhance performance when necessary. The Vanderbilt Coordinating Center (VCC) provides comprehensive support for a diverse array of clinical and translational research projects. Established 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 trials, including site selection, start-up, enrollment management, site engagement, monitoring planning, regulatory documentation, data cleaning activities, and trial close-out. You will work closely with sponsors and other functional team members to ensure effective communication and leadership throughout the trial process. Your role will also involve identifying challenges to study timelines and deliverables, offering creative action plans, and maintaining team focus on study priorities through efficient cross-functional partnerships. You will be responsible for overseeing regulatory compliance at participating clinical trial sites, maintaining safety profiles, and ensuring that all applicable regulations are met during project initiation. Additionally, you will develop and implement processes for trial coordination, create training materials, and oversee data management to ensure the accuracy and completeness of datasets before analysis and publication.

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.
• Responsible for establishing consistent methods for study communication to keep the project on track and foster collaboration.

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 leadership and communication skills
• Ability to work collaboratively in a team environment
• Proficiency in data management and analysis tools.

Benefits

• Comprehensive health insurance
• 401k retirement plan
• Paid time off and holidays
• Professional development opportunities
• Supportive work environment that values diversity and inclusion.